Recent events

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biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Recent events

Post by biopearl123 » Sat Sep 29, 2018 2:15 am

For good reasons I have avoided the computer for the last 24 hours so much of this may have already been brought up and discussed. My initial reaction was much like most and was summarized in yesterday's post. This is not the disaster purported. Its not even the disaster that accompanied yesterday's dread. Let me start with MF. Janssen has planned to file in MF in 2019 according to their presentations. (Or maybe later, but they planned to file). They would not have planned to do so in MDS since a phase III was clearly going to be required--more on this later. So to MF--in R/R the market is small. (It will get bigger as R/R patients live longer and continue to need drug), but clearly MDS was Janssen's target because of market size and presumed long term treatment need e.g. lots of drug over a patient's lifetime. So unless the FDA told Janssen to fuggetaboutit re MF there probably has been no change in filing plans for R/R. Geron now owns it all. Its a minuscule market for the Janssen giant but a substantial one for Geron who right now needs a win. If ASH confirms MOS which as of now appears to exceed 23 months (by perhaps a lot) then there should be significant pressure to approve, especially if >30% of patients have symptom improvement. We have discussed the ethics of the absence of a control arm and FDA has made clear that they are aware that studies involving end stage patients may not need one. A 10% shrinkage of spleen not important? Well when I have 10 % shrinkage its noticeable (That was a Seinfeld joke in case you missed it.) So I think there is a substantial likelihood Geron will get the R/R indication in 2019 and also that Janssen doesn't care because the market is too small for them. Janssen's decision to leave the partnership does not change this and probably relieves them of some burden. Now for MDS, to my knowledge there are no ongoing trials in MDS (CKTC==help me here) but nothing came up on the clintrials site. And the results are just amazing. This 30% TI rate not being adequate is ridiculous (without getting into subgroups like treatment naive patients). First off its a great outcome in and of itself. However "perfection is the enemy of good". How can a complete independence from tx overlook the importance of a substantial reduction in tx? Hoosier Investor has made this point among others that if a patient has a 14 unit tx requirement a month and it goes to one transfusion it DOES NOT ALLOW inclusion in the TI category. I think a big picture view is important. So to the mystery as to why this wasn't good enough for Janssen. I just can't figure it. Either they have something better somewhere (where ??) or they are abandoning MDS altogether--very doubtful especially after all the "commitment" to treating hematologic diseases. It has to be the former but I just don't see largeJanssen clinical trialsin MDS so I am going to have to reserve judgement. The last Wang study with the illustration that shows compression of malignant clone cells into a small compartment is quite impressive and suggests a strong potential clinical response and also fewer malignant clone cells that might evolve to AML. So here I at more of a loss. Please share any ideas you might have in this regard. My only conclusion is the Janssen thinks they have something better. And if they think that, then they probably do but its got to take some time to study and market and Geron has the P III ready to go. Regarding other indications, the strength of the combination studies (Abbvie etc) may just be strong for Janssen to take on--I highly doubt that too. To me the irony is that Imetelstat appeared to be a very good front line MF drug and we would be done with this agony if it hadn't been stopped in its tracks. ASH will be important not only for Geron but also for us to see what Janssen may have passed them over for. At that point maybe things will get clear. In the meantime maybe John Scarlett should start being forthcoming with his shareholders and tell us why Janssen passed so we can actually evaluate this situation in a fair and reasonable way. I hope everyone is recovering from the shock of yesterday. Maybe we will see a new partner soon. Regards to all bp

huntingonthebluffs
Posts: 246
Joined: Wed Feb 24, 2016 12:00 am

Re: Recent events

Post by huntingonthebluffs » Sat Sep 29, 2018 4:56 am

Thanks biopearl, great thoughts again. Therapy for us who know this can't be right but have to deal with the realities.

Dogonenuts
Posts: 40
Joined: Tue May 10, 2016 6:13 pm

Re: Recent events

Post by Dogonenuts » Tue Oct 02, 2018 2:57 am

My thoughts. If the ASH data were so good Janssen would have held on. I have no confidence in Scarlett and the board at this point. His statements of derisking the drug were very misleading and I think criminal to an SEC interpretation. I have been in this drug a long time and sold logging a loss that was staggering, but glad I did. I appreciate everyone’s hope in the science, but mine is dead at this point. I just have to wonder if a trial for first line therapy might not have been done except for the hold way back when. The lack of responses calls to question the veracity of Tefari and The Clinic IMO.

I really hate it for the Johns, Fishermagnets, and my cousin who could have benefitted from successful front line therapy. My faith in the whole system for drug development is blown! There, I feel a little better. Actually, I have been at peace with the whole thing as I knew I was taking an outsized risk, but the science, job postings and other bs were, well just that.

Going to build a turtle island in the creek behind my house.

1bordersooner
Posts: 17
Joined: Thu Jul 26, 2018 5:52 pm

Re: Recent events

Post by 1bordersooner » Tue Oct 02, 2018 3:24 am

Excellent post BP and thanks.

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