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YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. product candidates being greater than anticipated; the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficie...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. being developed by multiple other companies, to our knowledge, there are no mTOR inhibitors approved specifically for the treatment of advanced malignant PEComa other than FYARRO. As such, the devel...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. in trial protocols, differences in size and type of the patient populations, differences in and adherence to the dose and dosing regimen and other trial protocols and the rate of dropout among clini...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. market FYARRO for additional indications or for any other product candidates we may develop in the future. If we are required to conduct additional clinical trials or other testing of our product be...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. ) have the drug removed from the market after obtaining regulatory approval. Even if regulatory approval is secured for any of our product candidates, the terms of such approval may limit the scope a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. alone or in combination with other approved products or investigational new drugs, we may need to conduct additional studies to further evaluate the product candidates’ safety, interrupt, delay or a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. our product(s) and generate revenues, and may harm our business, financial condition and prospects significantly. For example, in our AMPECT trial of FYARRO, most treatment-related adverse events we...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Patients in our completed and planned clinical trials may in the future suffer other significant adverse events or other side effects not observed or anticipated based on our preclinical studies or p...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. deaths or other adverse medical events due to other therapies or medications that such patients may be using or due to the gravity of such patients’ illnesses. For example, it is expected that some ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. clinical research at any time for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks or adverse s...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. if any of our product candidates obtains regulatory approval, toxicities associated with such product candidates and not seen during clinical testing may also develop after such approval and lead to...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. preclinical studies or early-stage clinical trials. 48 Table of Contents Results from early preclinical studies and clinical trials of FYARRO or other product candidates that we may develop in th...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. trials. Similarly, even if we are able to complete our planned preclinical studies and clinical trials according to our current development timeline, the results from such preclinical studies and cl...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or EMA approval. We are subject to risks relating to open...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. aware when they are receiving treatment. Open-label clinical trials may be subject to biases, including a “patient bias” where patients perceive their symptoms to have improved merely due to their a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. patient data become available or as additional analyses are conducted and are subject to audit and verification procedures that could result in material changes in the final data. From time to time...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. fully and carefully evaluate all data. As a result, the topline results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and final data could significantly harm our business and prospects. Further, additional disclosure of interim data by us or by our competitors in the future could result in volatility in the price o...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , our ability to obtain approval 49 Table of Contents for, and commercialize, FYARRO in other indications or any other product candidates that we may develop in the future may be harmed, which cou...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . As part of these collaborations, we may grant such collaboration partners with the right to develop and commercialize the same compounds licensed to us, including FYARRO, in such foreign jurisdicti...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and/or maintenance of patients in clinical trials, our regulatory submissions or receipt of necessary regulatory approvals could be delayed or prevented. We may not be able to initiate or continue ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. for our trials for the TSC1 & TSC2 study are screened using genomic information to identify alterations in the TSC1 & TSC2 genes and utilizing such criteria and/or certain highly specific criter...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. each such alteration in the approved label. We may also engage third parties to develop companion diagnostics for use in our clinical trials, but such third parties may not be successful in developi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or potentially preventing us from completing recruitment for one or more of our trials. Patient enrollment and retention for our current or any future clinical trials may be affected by other factor...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. appropriate competencies and experience; clinicians’ willingness to screen their patients for biomarkers to indicate which patients may be eligible for enrollment in our clinical trials; 50 Table...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. report in clinical trials of our product candidates may make it difficult or impossible to recruit and retain patients in other clinical trials we are conducting. Similarly, negative results reporte...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the treatment and any follow-up periods. In addition, we rely on clinical trial sites to ensure timely conduct of our clinical trials and, while we have entered into agreements governing their servi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. selective inhibitor, and FYARRO in KRAS G12C mutant non-small cell lung cancer (NSCLC) and other solid tumors. Patients may not be able to tolerate FYARRO or any of our future product candidates in...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the therapy used in combination with such product candidates, or safety, efficacy, manufacturing or supply issues could arise with these e xisting therapies. In addition, it is possible that existi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. any product candidate in combination with any such unapproved cancer therapies that do not ultimately obtain regulatory approval. If the FDA, EMA or other comparable foreign regulatory authorities ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. for use in combination. Any setbacks in these companies’ clinical trials, including the emergence of serious adverse effects, may delay or prevent the development and approval of our product candida...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. candidates that may ultimately prove to be more profitable or to have a greater likelihood of success. We are currently focusing our resources and efforts on developing and commercializing FYARRO f...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. drugs. If we do not accurately evaluate the completed clinical trial data, likelihood of future clinical trial success, commercial potential or target markets for FYARRO or any of our other product ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. technologies, intense competition and a strong emphasis on proprietary and novel products and product candidates. Our competitors have developed, are developing or may develop products, product cand...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. we seek approval. This may make it difficult for us to replace existing therapies with our products. In particular, there is intense competition in the field of oncology. We have competitors both i...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. indicated specifically for the treatment of advanced malignant PEComa. Patients with malignant PEComa commonly receive chemotherapy regimens and currently mTOR inhibitors including sirolimus, everol...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. competition from other drug candidates in clinical trials that target the mTOR pathway. These may include dual mTORC1/2 inhibitors in clinical trials or next generation mTOR inhibitors in developmen...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or to in-license novel compounds that could make the product candidates that we develop obsolete. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. effective, have fewer or less severe side effects, are more convenient, have a broader label, are marketed more effectively, are more widely reimbursed or are less expensive than any products that w...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. less competitive or not economical. If we are unable to compete effectively, our opportunity to generate revenue from the sale of FYARRO or any product candidates we may develop in the future, if ap...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. carry the risk that they will not achieve these intended objectives. Any of these changes could cause FYARRO and any other product candidate that we may develop in the future to perform differently ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. we plan to leverage our leadership team’s prior business development experience as we evaluate potential in-licensing and acquisition opportunities to further expand our portfolio, we may not be ab...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment, or at all. If we are unable to successfully license or acqui...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may develop in the future. For example, we may be sued if FYARRO or any other product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing,...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. our products, our (or third-party) manufacturing processes and facilities or our marketing programs. FDA, EMA or other regulatory authority investigations could potentially lead to a recall of our p...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. we may be unable to obtain or maintain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have an adverse effect on our business and...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 19 pandemic has caused significant disruptions to the United States and global economy. Further, infections and deaths related to COVID-19 are disrupting certain healthcare and healthcare regulatory ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. clinical trials have been, and may continue to be, affected by the closure of offices, or country borders. Constraints surrounding hospital resources, infrastructure, staff and other resources, can ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; interruption of key clinical trial activities, such as cl...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. receiving, supplies of our product candidates from our contract manufacturing organizations (“CMOs”) due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems,...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and refusal of the FDA to accept data from clinical trials in affected geographies outside the United States. The extent of the impact of the COVID-19 pandemic on our future liquidity and operatio...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and Other Legal Compliance Matters If the FDA does not conclude that a product candidate and/or new indications satisfy the requirements under the 505(b)(2) regulatory pathway, or if the requiremen...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may not be successful in obtaining FDA approval under 505(b)(2) regulatory pathway for other indications or product candidates that we may develop. Section 505(b)(2) of the Federal Food, Drug, and ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. for an approved product. The FDA requires submission of information needed to support any changes to a previously approved drug, such as published data or new studies conducted by the applicant or c...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. additional indications or other product candidates that we may develop in the future or foreign regulatory approval for FYARRO or such product candidates that we may develop in the future and, as a ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. before a new drug can be approved for marketing. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. we cannot provide a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. increased costs due to new government regulations, including future legislation or administrative action, or changes in FDA policy during the period of drug development, clinical trials and FDA regu...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. response to the COVID-19 pandemic, after foreign and domestic inspections of facilities were largely placed on hold, the FDA has been working to resume routine surveillance, bioresearch monitoring a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the FDA is unable to complete such required inspections during the review period. Any delay or failure in seeking or obtaining required approvals would have a material and adverse effect on our abi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. centers that have undergone specialized training, limiting treatment to patients who meet certain safe-use criteria and requiring treated patients to enroll in a registry. These limitations and rest...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for FYARRO for additional indications or other product candidates that we may develop, we will...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. Even though FYA...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , regulatory approval may be delayed for reasons beyond our control. For example, a United States federal government shutdown or budget sequestration, such as ones that occurred during 2013, 2018 and...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. persuade the FDA that our product candidates, or the clinical trials that support their approval, contain deficiencies. Such actions by our competitors could delay or even prevent the FDA from appro...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval; the FDA, EMA or other comparable foreign regulatory authorities may disagree wi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. This lengthy approval process, as well as the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. countries in the future. The acceptance of study data by the FDA, EMA or other comparable foreign regulatory authority from clinical trials conducted outside of their respective jurisdictions may be...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. clearance for commercialization in the applicable jurisdiction. We are subject to risks relating to regulatory uncertainty in foreign jurisdictions. Brexit and uncertainty in the regulatory framew...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. existing regulations may increase our development lead time to marketing authorization and commercialization of products in the European Union and/or the United Kingdom and increase our costs. We ca...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. candidate in those countries. However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. Approval proce...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. our products is also subject to approval. Obtaining foreign regulatory approvals and establishing and maintaining compliance with foreign regulatory requirements could result in significant delays,...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. available in the United Kingdom, Great Britain (England, Scotland and Wales) or Northern Ireland, in addition to the national procedure. As with the European Union position, a company can only start...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , the United Kingdom regulatory approval process is likely to remain similar to that applicable in the European Union, albeit that the processes for applications will be separate. Longer term, the U...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. product candidate we may develop in the future for which we obtain marketing approval could be, subject to a comprehensive regulatory scheme, which includes the regulation of manufacturing processes...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , patient registries and other risk minimization tools. Any REMS required by the FDA may lead to increased costs to assure compliance with new post-approval regulatory requirements and potential requ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. practices (“GCPs”) for any clinical trials that we conduct post-approval. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced i...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. a medication guide, special training for prescribers and dispensers, and patient registries. As a condition of the approval of the NDA for FYARRO, we are required to conduct certain post-marketing r...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Contents regulatory authorities may require that contraindications, warnings or precautions be included in the product labeling, including a boxed warning, or may approve a product candidate with a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. indications, we may be subject to enforcement action for off-label marketing. Violations of the Federal Food, Drug and Cosmetic Act relating to the promotion of prescription drugs may lead to a numb...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. uance of warning letters, safety alerts, dear-healthcare-provider letters, press releases or other communications containing warnings regarding the product that would result in adverse publicity; vo...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. in or the rejection of approvals of additional indications for FYARRO; restrictions on our ability to conduct clinical trials, including full or partial clinical holds on, or the suspension or term...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. applications or supplements to approved applications filed by us. The occurrence of any event or penalty described above may inhibit our ability to commercialize FYARRO and any other product candid...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. marketing and promotional claims that may be made about prescription products, such as for FYARRO. In particular, a product may not be promoted for uses that are not approved by the FDA or such othe...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. on behalf of us, are found to have promoted such off-label uses, we may become subject to significant liability. The United States federal government has levied large civil and criminal fines agains...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. candidates or new indication that we may develop, and if we fail to obtain or face delays in obtaining FDA approval of such companion diagnostic product, we will not be able to commercialize such pr...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. companion diagnostics, we or our collaborators will need to address a number of scientific, technical, regulatory and logistical challenges. According to FDA guidance, if the FDA determines that a c...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. separate regulatory clearance or approval prior to commercialization. The approval of a companion diagnostic as part of the therapeutic product’s labeling limits the use of the therapeutic product ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the FDA issued new guidance on developing and labeling companion diagnostics for a specific group of oncology therapeutic products, including recommendations to support a broader labeling claim rath...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. impact our ability to generate revenue from the sale of our approved products and our business operations. Additionally, we may rely on third parties for the design, development and manufacture of ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of the companion diagnostic. We and our future collaborators may encounter difficulties in developing, obtaining regulatory approval for, manufacturing and commercializing companion diagnostics simi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. we contract may decide to discontinue selling or manufacturing the companion diagnostic test that we anticipate using in connection with development and commercialization of any such future product ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. designations from the FDA for FYARRO or any of our other product candidates. Even if one or more of our product candidates receive Fast Track designation, we may be unable to obtain or maintain the ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. alterations will qualify for or that we will be able to take advantage of the expedited review procedures or that we will ultimately obtain regulatory approval of FYARRO in other indications. Even th...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to facilitate the development and expedite the review of therapies intended for the treatment of a serious or life-threatening condition which demonstrate the potential to address unmet medical need...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. if our clinical trials are delayed, suspended or terminated, or put on clinical hold due to unexpected adverse events or issues with clinical supply, we will not receive the benefits associated with...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or other diseases. Breakthrough Therapy designation is for a product candidate that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threate...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the development of the product candidate; providing timely advice to, and interactive communication with, the sponsor regarding the development of the product candidate to ensure that the developmen...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. a Fast Track or Breakthrough Therapy designation for a drug. Obtaining a Fast Track or Breakthrough Therapy designation does not change the standards for product approval but may expedite the develo...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. prevent the FDA, EMA or other comparable foreign regulatory authorities, from approving competing products. Regulatory authorities in some jurisdictions, including the United States and the Europea...