March 14th

[biopearl123]

Am tied up with an all day commitment on March 14th so I won’t be posting in real time but will review the meeting once it is archived. Don’t interpret my lack of posting that day as a lack of interest (!!). If anyone can post a distillation of issues discussed and the temperature of the ODAC, it would be appreciated and I should have time to review the meeting over the next few days. Thanks, bp

[LWS]

Webcast Information
====================

March 14, 2024 Meeting of the Oncologic Drugs Advisory Committee (ODAC) Webcast Information The Center for Drug Evaluation and Research (CDER) plans to hold the March 14, 2024, meeting of the Oncologic Drugs Advisory Committee virtually via YouTube platform. Please note that the YouTube live video of the meeting will not broadcast until the meeting begins at approximately 9:30 a.m. ET on March 14, 2024.


While CDER is working to ensure that the YouTube video feed is stable throughout the meeting, there may be instances where its transmission is interrupted; staff will work to re-establish the transmission as soon as possible. CDER plans to post archived webcasts after the meeting.


A YouTube broadcast of the meeting can be accessed at the following web address: https://youtube.com/live/Om-cKKBsMS4 General Information: Please direct all technical inquiries to the appropriate support (listed below): Virtual-WOCC-Support@fda.hhs.gov


For further information regarding YouTube video feeds and archived webcasts, and for contact information of staff available to assist with questions, please visit the “Human Drug Advisory Committees” page of the FDA website at: https://www.fda.gov/advisory-committees ... y-committe

[jayfish101]

I like that there are MDS patients on the panel. I believe there are two. Also MM patient. Very large number of people on the panel.

[jayfish101]

I find the pro Geron presenters to be very knowledgeable and impressive. The FDA presenter had bad body language and gave off vibes of dishonesty and anxiety over being dishonest. IMO

[KTArsenal]

Yep, the very first FDA presenter was visibly nervous and her voice was incredibly shaky.

Faye Feller is just an incredible orator. She's a home run hitter.

[Zhears]

Watching the meeting.

Are the ODAC meetings always like this? The FDA seems to be acting like a prosecuting lawyer.
With the evidence the FDA has put forward, if half of it is true, shouldn't they have addressed it years ago or canceled the trial?

Is this the time-honored management game of moving the responsibility to the odac panal and there is still good chance that it will be approved?

[KTArsenal]

The safety review team never cancelled one MDS clinical trial, either.

I've got to believe that the FDA has to be hyper-critical and overly dramatic concerning safety and efficacy with a new molecule applying for an NDA.

So far, Dr. Feller is just so good. If we get an approval nod from this committee, thank her. And also a wink and a nudge to Dr. Savona as well.

[Ryan]

The Geron team and collaborators are indeed doing a great job.

It’s hard not to characterize the FDA teams posture as being prosecuting attorneys. Ultimately this is nerve wracking as they are of course the ultimate arbiter as to if the drug is approved and the labeling.

So I stick with my call that ODAC will overwhelmingly vote to recommend this drug, however the 3 months between now and June are certainly not set in stone or black & white as to how the FDA regulator marketing authorization will go… and take that from a Pollyanna.

[kmall]

Still don't understand why Geron didn't pursue approval in the UK before the FDA, a huge missed opportunity and would have strengthened any argument before the FDA. -Kmall

[KTArsenal]

I believe--could be wrong--it's faster to approval here in the U.S. than it is abroad, believe it or not. That's one scenario.

I think the other is the FDA is the "gold standard" for a drug's approval process. Unless you're big pharma, and then it's basically a rubber stamp from the FDA.

[Ryan]

Speaker #1 in the Open Hearing: MDS Doctor / expert in Canada. Had 3 patients in study and described experience of one, who was unblinded...

She used the phrase "incredible drug", and "impressed". Halelujah moment for sure!

Not that we did not know of these efficacy effects, however we did need this anecdote and expert (non-sponsor) testimony.

[huntingonthebluffs]

Maybe my glasses are just to rose colored but while the FDA may have a right and need to play the devil’s advocate role, there is no justification for misconstruing the facts on AE’s or misusing statistics to water down the various strengths and stellar results of the CTs whose design they signed off on.

The Geron team led by Dr Feller, is doing a great job. Taking the high road, as they must, has to be frustrating in view of what is IMO clearly unprofessional sinister tactics being used by the FDA. The FDA's performance in this meeting are in object indifference to the doctors in the field stating their opinions on efficacy, safety and patient QOL experiences and Geron’s professional and medical efforts through out the CT processes to bring this needed drug to the market.

I don’t think I’m overreacting when I say there is clearly something rotten in a US Government Agency that is crucial to all our well beings. I think the vote will go part way in setting things right but we'll soon see.

[Ryan]

Speaker #2 is equally "enthusiastic" (her word). She is a non-sponsor patient advocate with the MDS Foundation.

Seems the tide has definitely taking a decidedly (and maybe expected) +++ positive turn as the talk turns from anecdotes and real stories as compared to the data jargon...

[Ryan]

Speaker #3 was a patient from TX, who said she was ready to meet the Lord upon hearing her treatments were not working. Before Imetelstat... needless to say, amazing story.

Speaker #4 is Dr / expert from Cornell, non-sponsored who had consulted with Geron in the past....
"Enthusiastic to have Imetelstat as a treatment option."

Period.

[KTArsenal]

Again, I believe the FDA *has* to be heavy-handed in regards to efficacy and safety profile.

After all of the human MDS stories using imetelstat and doctor's approvals for using imetelstat, this committee would be ghoulish to not approve imetelstat for a therapeutic option in MDS.

Period.

[Ryan]

Speakers 8 and 9 were patients. They were extremely compelling and 100% advocating for Imet. Dare I say, tear-jerkers...

9 Speakers was 9-0 in favor of Imetelstat.

[kmall]

KT - FDA being the "gold standard" has been the case since before I've been breathing air, but the MHRA Innovative Passport was implied over 3yrs ago. With the team in place there, and the UKs acceptance of alternative treatments, Geron may have had a year or more of RWD to present here today. It would of made an even stronger argument. Of course all speculation. -Kmall

[mistergern]

I believe "the chute' has opened and we will land safely - hope I'm right - glta!!!

[earfool]

Voting in progress.

[ashah]

Very entertaining... worst fear than any horror movie I have seen. Would have been perfect... except this is real life, impacting real patients and real families.
I am ashamed at the incompetent FDA members and the panelist who voted no. May their family and friends never get this disease.