No press release yet

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biopearl123
Posts: 409
Joined: Fri Jul 20, 2018 5:13 pm

No press release yet

Post by biopearl123 » Tue Aug 04, 2020 10:03 pm

The fact that EU orphan designation has been granted to MDS as anticipated in the PR of early July, this could be viewed as a formality but one I would think that warrants a press release rather than having the minions like us searching data bases to confirm this event. This suggests to me that additional news is forthcoming and will be shared on Thursday at 4:30 PM along with the earning report. Since OD should open the gateway to MA it certainly seems that events in the past need to be evaluated in light of this. For example, we know that MF was granted EU OD about four years ago but did not open the gateway. I think this was in anticipation of confirmatory data from the Janssen study which we know did not materialize. We also know that the MDS data of four years ago did not even warrant OD recognition. Now with two new confirmatory PII studies presented in an International forum it is reasonable to assume that this data has been submitted not only to support OD in MDS but also MA in both indications. So the question is what does it take to make the leap from OD to MA? MF could not do it four years ago and either could MDS. The question is whether the data now is a strong enough bridge to do so (the KOLs seem to think so), and will the PR on Thursday give us some indication at to whether this is possible. As others have pointed out that we now have strong quality assurance, manufacturing, clinical personnel. I doubt these folks are in place to support a 2024 approval line for the US. A three and a half year runway seems excessive to build such strong departments now unless European approval in in sight sooner, much sooner. One thing about an OD application, I doubt Geron would have much to say until actual approval. The reason is obvious, if it were rejected, (as might have been the case with MF and a reason Janssen walked), they would never want this information to become public. This is not to say they would not get further data or try to fulfill whatever further requirements might be established by the EU, just that we would never know about it. bp

rccola335
Posts: 54
Joined: Sat Sep 28, 2019 10:00 pm

Re: No press release yet

Post by rccola335 » Wed Aug 05, 2020 3:11 am

look at the time line for the July 1 press release - june 18th EMA commission met and June 25th they recommended OD - Geron did not release this until July 1
are they waiting for an official certified letter before they publicly disclose? This seems like something you would want a premarket press release

rccola335
Posts: 54
Joined: Sat Sep 28, 2019 10:00 pm

Re: No press release yet

Post by rccola335 » Thu Aug 06, 2020 2:57 am

someone on yahoo said CG capital and Geron parted ways on July 31 - I suspect it was earlier than that - the PR's in June listed CG Capital on the bottom but after that Geron stopped listing them at the bottom of the pages -

rccola335
Posts: 54
Joined: Sat Sep 28, 2019 10:00 pm

Re: No press release yet

Post by rccola335 » Fri Aug 07, 2020 12:59 pm

On July 1 Geron issued a press release that the European commission recommended Orphan status. July 27th they actually received Orphan status but decided not to issue a press release. Hmmmm.... The stock price was 2.15 on July 1 and now under 1.70. It is almost as if they want to encourage the stock price to fall.

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