ImetelChat

Ryan, I wish it were that straightforward. Get OD is a good thing but unless we see some glimmer of MA, the significance will be similar to the OD that was designated long ago in the US. For Fish’s sake and his work and thoughtfulness I hope this leads to MA in the EU soon but it’s still not a foreg...

Bill, some side effects can be pretty significant:
http://www.haematologica.org/content/ea ... l.pdf+html

When asked directly about potential competition, the door was opened for a direct answer but one was not received (except for a nod to Constellation Pharma). Therefore I have to conclude that this therapy, while very promising (but expensive) does not pose an immediate threat. I think CAR-t has bigg...

From the EMA when OD was granted for MF: "Designated orphan medicinal products are products that are still under investigation and are considered for orphan designation on the basis of potential activity. An orphan designation is not a marketing authorisation. As a consequence, demonstration of qual...

Sorry about the Kamall, kmall, I know you better than most of the other posters but my spell check does not. bp

Hi Kamall, sorry you had trouble posting before, as you know we have glitches with this site for reasons discussed previously. It was great to hear from you, I was afraid you had been blown off course and ended up on an island previously only inhabited by a FedEx guy. Thank you for your research and...

Recently an article in the Wall Street Journal highlighted a list of co morbid conditions that predisposed to death should a patient get COVID. The data was taken from the unimpeachable journal "Nature". The highest risk co morbidities list was headed by blood and bone marrow cancer. Higher risk tha...

Hi Ashah, I think the jist of where I saw this going (perhaps because of an over active imagination) was that an application for Market Authorization in the EU has some mechanism to proceed in parallel to that of Orphan status. It does not appear that they necessarily have to occur in series. In a p...

https://ir.geron.com/investors/press-re ... fault.aspx

One can only hope they are building a sales force but Dr. Scarlett has alluded to expanding research capabilities (in house lab research?).

‘ https://www.clinicaltrials.gov/ct2/hist ... udyPageTop

Thank you CKTC for clarification. Does this arrangement "protect" the board's current composition and guard against a large investor's potential influence on decision making? These recent investors are pretty big hitters and to HI's point would likely wish to influence the company's direction. bp

FC4364, Having an oral drug approved is definitely an important event but the Astex combination is approved for high risk MDS and CMML, a little bit of a different disease universe. So far I am not sure if there is overlap with the lower risk group that Imetelstat targets. I agree that no clinical n...

High risk MDS/AML has a rare spontaneous remission rate. Here is what I found so far: https://ashpublications.org/bloodadvances/article/3/18/2696/374950/Patients-with-spontaneous-remission-of-high-risk They report a 64 year period with 46 cases each a little different. Its pretty rare. Not too sure ...

Is the ownership not limited to under 10% for each entity? Not sure if any one investor has the firepower to command a board seat but if they do, they would almost certainly try to monetize sooner. For us old guys that might be good but the full potential of the company might not be realized if a ta...

rccola335, Good point about potential transmissibility of virus. Considering that other blood borne diseases like malaria, Chagas, HIV, prions etc can be transmitted, would not be surprised to see cases of COVID as well.

Hi Ashah, I think the answer lies in Geron needing data to differentiate it from Luspatercept which they now clearly have. bp

Ashah, I think your question re EU becomes even more relevant and prescient given recent events. Even if the EU does not value RWD in the same way we had hoped the FDA would (and as they seemed to indicate via various guideline papers they published), it does appear that after orphan status is grant...

Lekola, have thought about your questions and have some preliminary thoughts. First off, happy Fourth to all board members we are most fortunate to be part of this country despite or perhaps because of its many problems. My father was a WW II vet also (medical corps) in the Philippines. He once said...

Hi Ryan, right. Its deja vu all over again. 5 years ago I suspect Janssen thought they had an MA sown up for MF, 1. Unmet medical need 2. Requisite small treatable patient population 3. Plans for confirmatory data AND wait for it-- good PII data--NOT. As we know this one check box was not ticked and...