A note from your board moderator

[biopearl123]

Just got home after important family obligation. Obviously a lot has happened but was able to intermittently tune in. Geron hit it out of the park. Great presentations all around. Masterful, informed, confident. I was struck by a couple of things besides what has been discussed here today. Did I understand Faye correctly that there is a patient is entering his or her 4th year of treatment? Pretty nice.(Was that 4 years of TI or 4 years of treatment)? The doctor /patient comments couldn’t have been more appropriate, moving and supportive. The Viet Nam Vet who spoke was doing great and might even take golf back up, one wonders about Agent Orange exposure as highlighted by Kmall. Let me digress for one moment before returning to this thread. Recently there were some harsh comments on the board which unfortunately I let stand when they should have been deleted. They are now and I apologize to anyone I may have offended in the process. Just thought that with emotions running high, we might also get some spirited discussions. I was wrong. Mia kulpa. Please forgive and move on. Back to today’s presentation. The FDA’s presenter was basically sent into the lions den. The two panel negative votes had to be to show some support for their FDA colleague. She was tasked with a difficult job which she did admirably even if she tried to skirt the IWG guideline issue a bit. Knowing that the 2018 guidelines were part of the FDA approved protocol once part two started, helps. The other issue I thought interesting was a lot of air was given to the lack of CR/PR etc but how in the world do you assess that in L/R MDS when by definition, the blast % is <5%? Have to leave that one to the experts. I do think the FDA was obligated to make the arguments they did, just like in a court of law. It reminded me of a time I was covering the pacemaker service at a local hospital decades ago and was called in for an emergency. Got a ticket speeding in which I decided to fight. In court, there was actually a prosecuting attorney (I was defending myself) who did everything he could to paint me in a bad light. I asked the judge if this was proper behavior, after all I really needed to get to the hospital to do something important. He said that attorney was just doing his job and that is what he was trained to do. The FDA serves us well by trying to look at problems from all angles and they certainly did. But imagine the two no votes having to explain themselves to the patients who were brave enough to share their stories? In my private correspondence I advised people not to sell or to buy, that is way out of my purview, but just to stay strong. Now my advice is simple: breathe!

[CKTC]

@biopearl123

I have a theory as to why the FDA came out swinging so hard on the efficacy issue when it should seem obvious to most that the drug works. The real challenge for Geron with the FDA has been going on behind closed doors, and that’s the wording of imetelstat’s labeling. The drug’s side effects are well-known and however manageable, the FDA may be pushing for a boxed warning, or maybe even a REMS. Geron would be fighting this tooth and nail. Had the FDA succeeded in swinging the advisory committee to a more negative vote, it would have given itself more leverage in the label negotiations. That sounds rotten, but their actions would make perfect sense if this were a commercial transaction and the FDA a corporation.

[jingledsassy]

Special thanks to you Bp and Kmall....been a real long road...We are now on the bottom floor of the start of Curing Cancer.....With a couple of Partners and Combo's and super computer programs the Cure seems not far away....Still some wood to split......Land Ho!!!!!

[Zhears]

Has anyone watched other meetings like that and can say the FDA behavior is normal?

I thought it was disgraceful. If half of the things they claimed were wrong the study should have been canceled years ago.

I'll give it a few days in the hope of an answer, otherwise, I'll try and find some other recordings and report back.