Musings: For those looking (hoping) for early Brexit approval…

[biopearl123]

I think after all has been said and discussed that this will not happen. This despite the excellent case kmall and others (even I) have made to suggest this is possible. For one thing it is straightforward that the Brits have a separate system for approval, we all agree on that and Geron would have had to initiate the approval process in GB separately, and they did, we also agree on that. Early approval in GB allows for glitches that can accompany any approval to become apparent with early broader usage experience which could derail the FDA (and an acquisition). GB is a relatively small market. Better to wait, get all the ducks in a row and I mean a flawless NDA for the FDA even if that is a year away so as not to risk some early problem occurring in a non US market. The FDA would clearly apply the brakes in the US if that occurred. Geron knows this can’t happen. The nebulous misdirected remarks from Geron’s IR re the EU when specifically queried about Great Britain suggests to me that approval in the EU and GB will occur hand in hand and follow the US just as outlined in Geron’s presentations. Sorry guys, don’t get your hopes up too soon here. BUT what is much more likely to happen and has been telegraphed pretty clearly by Dr. Scarlett and Co., is a partner (probably European) or the possibility of out right acquisition well before then. Ryan has a great Silicon Valley word for this maybe he can help here. For those of us who parse Dr. Scarlett’s every word (I can’t be the only one, right?). He once said he believed that the time for a small biotech to be acquired was after good PII data on the way to PIII. He said those words many years ago but I doubt he has changed his mind—and they as much as told us they are actively talking talking to potential partners now. So here’s the first and maybe my only question for the shareholder’s meeting this year, (in contrast to the 20 or 30 I usually submit!—well maybe not that many). Is there a drug in PII or PIII that has been conclusively shown to result in disease modification and have a longevity effect (excluding BMT)? Now clearly we will need PIII Imetelstat data to say that about our drug but can anyone else? There is a lot of exciting stuff coming recapitulated by kmall on this board (thank you!!). And a lot of it is going to actually happen within the next 10 months so suck it up and wait it out but don’t look east to the Brits for it. Regards to all, bp.

[rccola335]

I agree, there will not be an early GB approval - there will not be an BO when the stock price is this low - Scarlet would like to sell but the price needs to be higher before we could get to a reasonable buyout number - they are forced to carry thru phase III which they have the team to do
1- a partner can and will raise the price but makes the BO stickier and worth less
2 - what news can raise the price soon - partner , GB approval , news from MD Andersen

[Ryan]

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