Interesting timeline (as we wait)

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Interesting timeline (as we wait)

Post by biopearl123 » Thu May 16, 2024 11:09 pm

Luspatercept was granted a plenary in 2018: "Dr. List discusses results from the MEDALIST trial in patients with transfusion-dependent myelodysplastic syndromes, which were presented as a plenary abstract at the 2018 ASH Annual Meeting."

Luspatercept was granted FDA approval for MDS in August 2023.

Imetelstat>>>Luspatercept by many parameters. High likelihood of approval within weeks. No plenary as yet. Guess we wait for ASH for that.

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Re: Interesting timeline (as we wait)

Post by LWS » Sat May 18, 2024 7:12 pm

All we can do is wait.

Most of us (on this board) believe that Geron's NDA for Imetelstat will be granted (very high probability). Still, no one has been able to explain the FDA's opening diatribe on March 14th, which was totally refuted by most of ODAC and other contributors (patients, blood cancer experts) and recently the EHA abstract (meeting June 13-16). No matter what the outcome, we will consider these opening statements by the FDA as an important reference point.

from LWS » Thu May 09, 2024

The 12 YES votes from ODAC should prevail.

No one trusts the FDA after their "devil's advocate" presentation at ODAC's March 14th meeting. Some think there is an "effort" by big pharma to prevent FDA approval of Imetelstat and that is holding the price down. It could shoot up rapidly (toward $10 as Cowen predicts) or collapse. We will know the answer on or before June 16th, when the FDA finally speaks.

Summary/Conclusion (from EHA abstract):

Results from these updated analyses confirm that achievement of RBC-TI with imetelstat was durable and associated with improvement in Hb level. Additionally, preliminary OS analysis suggests no detriment with imetelstat vs placebo.

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