ADCO comments

[jayfish101]

What does everyone think about the comments. They strike me as negative, but I have never reviewed adcom comments and agendas before. Does someone have experience/expertise in this area? The comments scared me into selling 2/3's of my holdings.

[mistergern]

BP, Could you clarify the following comment:

"Bridge, thank you for taking the time to clarify the context of your comment. Taken in context, now that the notes are actually out we don’t have to be concerned about the likelihood of the necessity of the FDA requiring an additional trial."

Why don't we have to be concerned of the necessity of the FDA requiring an additional trial?

[biopearl123]

Mistergern, you are right, I don’t really don’t know what the FDA will do. I was viewing this as an up or down vote. I just wanted to be sure Bridge had the opportunity to clarify his comments. My comments were based only on not seeing any statement in the FDA material that an additional study was warranted. The fact that the FDA has already allowed continued access to Imetelstat beyond the actual study was the basis for that comment.

[mistergern]

BP, Was there anything in the report that gave you pause or caused you to question the efficacy of imetelstat beyond any concerns you had to date?

[biopearl123]

Still reading and digesting. Might go back and buy the article recently published in Cell re disease modification. There is a lot in the FDA postings. Glad oncology experts will be able to debate the pro’s and con’s. CKTC’s point about the final question is central. I think it can be boiled down to “do the benefits outweigh the risks? “ The risks are well outlined and the benefits are approached by the FDA in a fairly harsh statistical manner. We have been hearing from heme experts who present and analyze data for years. Now they present to the FDA. It’s been a long road to get here and clearly Geron is optimistic knowing every objection the FDA would raise for discussion. They are ready. Clearly the market does not like what is in the FDA report but again, with an incurable disease, physicians who are well versed in managing side effects, clear cut benefit to subgroups of patients and the beginnings of the search for disease modification agents, and not so good agents currently available, do the benefits outweigh the risks? So sure plenty of reason for pause. But cancer gives us all reason for pause and we are in a risky stock that has shown pretty clear benefits for a number of patients. Best Wishes, and I really mean that. Will be back tonight once I read that last article. (Unless someone else wants to buy it, but no one ever does!)

[mistergern]

Thanks for your reply BP. It's hard not to agree with Jayfish that the FDA report had a negative vibe but it also seemed to be straining to identify risk while diminishing benefits - it did not seem balanced to me and may have been a CYA/Big Pharma pleasing effort. I've decided to stick it out and purchased more shares at $1.89 - hopefully, it's not a dumb move. Thanks again.