ImetelChat

Gwikley, I don’t have that answer but Dr. S mentioned in the past that a good yard stick would be a value similar to the reimbursement for Luspatercept. That should be in the public domain.

https://www.liebertpub.com/doi/abs/10.1 ... .2023.0014

We have speculated before, that a J and J purchase of Geron and MAIA would control the oligo space.

J and J is definitely a master of their own domain.

Ryan, nice dig. Investigators meetings are not made public. Perhaps a participant will post after the meeting but it certainly will not be open for public viewing, your are correct about this. As to Dr. Lane, his enthusiastic 2014 post ASH presentation has had to wait 10 years to see this drug in cl...

Thanks for posting this bucbeard, I still haven’t figured out what a portfolio consideration is. If J and J wanted it, they would have ponied up.

Right! By then they will all be ready for Imetelstat.

Unfortunately no. Not approved, no path to approval. Minimal data very preliminary.

Jay, this relates to FDA processs in general and is also quite interesting. I will allow it to stand on its own merits.

LWS, please be mindful of accuracy. Phase 4 studies are mandated post marketing studies. EAP is not that.

Good news. It’s a start.

Dr. Scarlett has counseled patience, as if it might be overlooked that we have not exercised this Confuscian quality to excess. Yet here we are with an accepted NDA, an undervalued event by the investment community. With the exception of IMerge, all on going studies have timelines that keep extendin...

There has always been a debate as to whether a study could be stopped early for overwhelming positive results. Only the DMSB would know this and clearly it’s an ethical issue that affects not just patients in the placebo group but all patients. But the statisticians according to what I read are relu...

DL 76, if only. This is a great question and similar to one I asked at a shareholders meeting maybe two or so years ago. Since the study design is a 2:1 randomization, the placebo group is much smaller than the treatment group. My question was how could they assess mortality as an end point if many ...

“biopearl, I saw your latest post on Imetalchat regarding EMA and MF approval. We know MF P3 has greater that 40% enrollment per JS. As you state, 30% of the patients have to die in order to trigger the first data look. Is it possible that at some point with a significant patient sample size, patien...

RC, also, with all the new hires at Geron it seems likely that the prior responsibilities farmed to PAREXEL have now been brought in house. As to your MF speculation (would that you were right!) it seems very unlikely unless approval relied on existing PII data (also unlikely). The PIII study is und...

I think you are right. They are slated to file in Europe “second half of 2023” so we should know more then.

RC this is a pediatric committee and a formality since there is no pediatric data or planned use in kids

Probably not. Just the slow restoration of sanity.