Vote 12-2 in Favor

[CKTC]

Nice win for Geron, imetelstat, and MDS patients. Now we need FDA approval.

[mistergern]

Kmall - you can start breathing

[bucbeard]

a strong day for Geron and the patient community that Imetelstat serves. Onward we go to approval.

Thank you to the members that make this discussion board special.

[Bigfun]

Phew! I could not watch all of it but seems to me that the less positive views expressed were because they were looking at the risk across the whole population of low-risk MDS. They were concerned about the risks to groups that would maybe not respond but still potentially be exposed to the side effects of Imet. On the other hand even those who expressed that concern still seemed impressed with the sub population that did respond and maybe wanted a better way to target that group so that responders could be identified so as not to bring folks into Imet who would not benefit.

Overall very positive at the end IMHO!

PS There were at least a few digs on the FDA using the old standards and trying to move the goal posts regarding agreed upon end-points.

[earfool]

I can somewhat understand the attack dog mentality of the FDA rep as Imetelstat is a first in class novel drug never before approved for any indication. The FDA rep was intelligent and very data literate….. but Imetelstat treatment approaches and outcomes that vary significantly based on individual patient circumstances and this inherent complexity made it easier for the DFA rep to question and highlight perceived shortcomings.

The FDA's rep hindsight bias seemed obvious to me unfairly coloring her perceptions of Geron’s decisions. Geron had to prove to the committee that Imetelstat treatment and efficacy was appropriate and the benefits outweigh the risks. Way more challenging than the FDA pointing out potential flaws or perceived errors in the study.

Well done Geron team in the face of adversity and challenge.

12 yes votes v 2 no votes.

Bravo
earfool....

[pursang]

Should've been 14-zip, but I'll take 12-2 ..

[kmall]

Mistergern........

[lacour_98]

It's always darkest before dawn. When watching/listening to the first FDA presenter, if I was an unstable type, I might have been looking for a bridge or cliff. Last non technical comment/question. Her kick-off certainly created a lot of stress - no wonder, trading was halted today.

[LWS]

Can anyone find a FDA rejection that happened after an ODAC recommendation?

The favorable vote from ODAC (cancers) for recommending Imetelstat contained 2 NOs (one surprisingly from the Chairperson). 97% of ADCOM (all medicines) recommendations are accepted by the FDA. However, no one can find an example of one that was rejected after an ODAC positive vote.

Has an ODAC recommendation ever been rejected by the FDA?

[KTArsenal]

Similar to a priority review pathway, an unmet need usually addressed by orphan products tends to increase the likelihood of approval.

Paraphrasing here, but you get the point.

Pink.citeline.com was used for this sourcing material.