For Imetelstat, I think we are in a great place. 5 month countdown is on (if that) and the chance of marketing authorization does seem a lock. The data though.
For GERN stock, given Week #1, expect max pain this year, IMO.
Off-Topic - GERN stock
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Re: Off-Topic - GERN stock
Geron has recently added a Sr. Director/Legal Counsel who started her career with the FDA. Perhaps this helps with the MA lock? -Kmall
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Re: Off-Topic - GERN stock
Geron has added (at expense) many layers of experts including those who specialize in being sure all the FDA t’s are crossed and i’s dotted. MA should be highly likely bolstered by virtually every expert we have heard who makes a point of emphasizing that the grade 3 and 4 cytopenias are actually “on target” rather than representative of direct bone marrow toxicity like so many other agents. Geron is prepared for the FDA no doubt, and the heme/onc community wants to get their hands on Imetelstat to help their patients. Unless the HR/AML patients don’t do well we should be on track. And yes it is reprehensible that the FDA has delayed approval for so long and denied priority review. No one can take them to task out of fear of bureaucratic retribution.
Re: Off-Topic - GERN stock
Nice piece of info and I align with the call.
However, I have little doubt that while we wait for marketing authorization, and perhaps even as Revenue begins, our ‘wait’ as investors will involve days and weeks of “max pain”. IMO, any small fry investor (eg most of us here) will need to ride it out without capitulating in order to see the fruits of our patience/fortitude. I highly doubt many here would capitulate, however again my guess is we are in for some more stomach churning moments (days, weeks). We’ll see, either way, it’s just a “matter of time”!
Re: Off-Topic - GERN stock
Ryan - This latest hire is based in Chicago and was at Abbvie for 3yrs......2+ as Manager, Global Strategies. Abbvie has been on an acquisition frenzy the past 2 months......not that it means anything here, but you never know? -Kmall