Vote 12-2 in Favor
Forum rules
- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
Vote 12-2 in Favor
Nice win for Geron, imetelstat, and MDS patients. Now we need FDA approval.
-
mistergern
- Posts: 221
- Joined: Sat Mar 19, 2016 3:48 pm
Re: Vote 12-2 in Favor
Kmall - you can start breathing 
Re: Vote 12-2 in Favor
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.
Thank you to the members that make this discussion board special.
Re: Vote 12-2 in Favor
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.
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.
Re: Vote 12-2 in Favor
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....
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....
Re: Vote 12-2 in Favor
Should've been 14-zip, but I'll take 12-2 ..
Re: Vote 12-2 in Favor
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
Re: Vote 12-2 in Favor
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?
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?
Re: Vote 12-2 in Favor
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.
Paraphrasing here, but you get the point.
Pink.citeline.com was used for this sourcing material.
Re: Vote 12-2 in Favor
I’m still having a hard time understanding why there was (is?) an issue on the FDA side about the # of Americans in the trial. On its face that seems racist to me. I assume the doctors and experts at the fda know that all humans are 100.0% biologically the same.
Does this have something to do with the processes of therapy and data collection in different countries?? Two months later I’m still troubled by that flippant talk from the FDA side about the patient nationalities.
Does this have something to do with the processes of therapy and data collection in different countries?? Two months later I’m still troubled by that flippant talk from the FDA side about the patient nationalities.
-
LWS
Re: Vote 12-2 in Favor
After all is said and done, the 12 ODAC YES votes will lead to the FDA approving Imetelstat (NDA).
The FDA clearly screwed-up using the 2006 (old analysis) rather than the 2018 (revised analysis) for the data related to transfusion independence (in their opening statement on March 14th). They were caught and rebuked by ODAC and other blood cancer experts. This will all be apparent in the EHA paper (June 13-16). An ODAC positive recommendation has never been rejected (as far as I can tell) by the FDA.
The FDA clearly screwed-up using the 2006 (old analysis) rather than the 2018 (revised analysis) for the data related to transfusion independence (in their opening statement on March 14th). They were caught and rebuked by ODAC and other blood cancer experts. This will all be apparent in the EHA paper (June 13-16). An ODAC positive recommendation has never been rejected (as far as I can tell) by the FDA.
-
biopearl123
- Posts: 2591
- Joined: Fri Jul 20, 2018 5:13 pm
Re: Vote 12-2 in Favor
I wouldn’t say they were rebuked, only that something important was called to their attention. We know and so do they that the IWG criterion are evolving and being refined as more about MDS is known. We also learned just how rigid the FDA can be when requiring a strict adherence to predefined protocol criterion. Fortunately Geron has anticipated the army of pedants that live there and had their ducks in a row and the pre defined study criterion in place. This prescience made evaluation of the data relevant and up to date. bp
-
LWS
Re: Vote 12-2 in Favor
The IWG (international Working Group) seems to be the key factor with their revised (2018) method of data evaluation.
My hope is that that Geron, MAIA, MD Anderson & U of Texas (with common interests) will all work together to find treatments and cures from blood cancers to solid cancers with advance delivery systems. The vital ingredient now is the FDA and the NDA approval of Imetelstat for TI (Transfusion Independence).
=============================
My hope is that that Geron, MAIA, MD Anderson & U of Texas (with common interests) will all work together to find treatments and cures from blood cancers to solid cancers with advance delivery systems. The vital ingredient now is the FDA and the NDA approval of Imetelstat for TI (Transfusion Independence).
=============================
Fortunately Geron has anticipated the army of pedants that live there and had their ducks in a row and the pre defined study criterion in place. This prescience made evaluation of the data relevant and up to date. bp
-
LWS
Re: Vote 12-2 in Favor
FDA must speak before June 16th
As far as I know, the FDA has never rejected a positive ODAC's (Oncology Committee) recommendation. 12 YES votes is overwhelmingly positive. In addition, Imetelstat has the support of the ASCO poster and the EHA coming oral paper (June 14th) authored by the world's top blood cancer experts.
What could go wrong?
As far as I know, the FDA has never rejected a positive ODAC's (Oncology Committee) recommendation. 12 YES votes is overwhelmingly positive. In addition, Imetelstat has the support of the ASCO poster and the EHA coming oral paper (June 14th) authored by the world's top blood cancer experts.
What could go wrong?
-
LWS
Re: Vote 12-2 in Favor
Approval --Most on this board expected approval, but Geron's past history of disappointments and the FDA's (devil's advocate approach) had all of us wondering. As it turned out, nothing went wrong, and the blood cancer experts prevailed. I am looking forward to the EHA oral presentation on June 14th (I believe).
================
================
As far as I know, the FDA has never rejected a positive ODAC's (Oncology Committee) recommendation. 12 YES votes is overwhelmingly positive. In addition, Imetelstat has the support of the ASCO poster and the EHA coming oral paper (June 14th) authored by the world's top blood cancer experts.
What could go wrong? -- LWS June 6