Official 8k notice of ODAC advisory meeting

[jayfish101]

Item 8.01 Other Events.
As previously disclosed, in August 2023, Geron Corporation (“Geron” or the “Company”) announced that its New Drug Application (“NDA”) for the
use of imetelstat for the treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes who have
failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents, was accepted by the United States Food and Drug
Administration (“FDA”) for review and assigned a Prescription Drug User Fee Act (“PDUFA”) action date of June 16, 2024. On January 30, 2024, the FDA
provided notice in the Federal Register that it has scheduled an advisory committee meeting of the Oncologic Drugs Advisory Committee as part of the NDA
review, to be held virtually on March 14, 2024, from 9:30 a.m. to 3:00 p.m. Eastern Time. The meeting will be open to the public. For additional information,
please see https://federalregister.gov/d/2024-01797.
Use of Forward-Looking Statements
Except for the historical information contained herein, this Current Report on Form 8-K contains forward-looking statements made pursuant to the “safe
harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, including, without limitation, those
regarding the PDUFA action date for Geron’s imetelstat NDA and the date of the scheduled FDA advisory committee meeting, constitute forward-looking
statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forwardlooking
statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: uncertainty of regulatory actions, approvals or
clearances, including the risks that the PDUFA action date for the NDA may be extended and that the FDA may ultimately determine not to approve the NDA in
its present form or at all; that the date for the FDA advisory committee meeting may be changed and the discussions at and outcomes of that meeting; whether
imetelstat may cause, or have attributed to it, adverse events that could further delay or prevent the commencement and/or completion of clinical trials, delay or
prevent its regulatory approval, or limit its commercial potential; if imetelstat is approved for marketing and commercialization, whether Geron is able to
establish and maintain effective sales, marketing and distribution capabilities, obtain adequate coverage and third-party payor reimbursement, and achieve
adequate acceptance in the marketplace; the future development of imetelstat, including any future efficacy or safety results that may cause the benefit risk
profile of imetelstat to become unacceptable; Geron’s need for additional capital to support the development and commercialization of imetelstat and to
otherwise grow Geron’s business; establishing and maintaining imetelstat manufacture and supply; the enforcement of Geron’s patent and proprietary rights;
managing Geron’s business growth; and potential competition. Additional information on the above risks and uncertainties and additional risks, uncertainties
and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s filings and periodic reports
filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s quarterly
report on Form 10-Q for the quarter ended September 30, 2023 and future filings and reports by Geron. Undue reliance should not be placed on forwardlooking
statements, which speak only as of the date of this Current Report on Form 8-K, and the facts and assumptions underlying the forward-looking
statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information,
events or circumstances.

[biopearl123]

I guess we have trustworthy confirmation now! Thanks for posting.

[Ryan]

At least it’s on that Thursday and not Friday…

Beware of the Ides of March.

Onwards…

[kmall]

Someone on the YMB had mentioned that March 14 is the day before quadruple witching? -Kmall

[rccola335]

Today is also a day of interest - 1/30/24