ImetelChat

I wonder if by taking its time to review the NDA now, Geron will be given a shorter PUDUFA date. In theory, since the application was granted rolling review, each module has already been closely examined by the FDA over an extended period of time with the possible exclusion of the last submitted mod...

Kmall, wellllll, I have no counter argument to your points. Not a one. This all should have happened a looong time ago. A long (insert word) time ago. “Fast track” is laughably euphemistic.

As we approach the NDA acceptance date, if you are feeling a little anxious, ask your self the following: 1. Are you aware of any agent in development or in the clinic that has shown conclusive disease modification in this condition. Answer: Yes you are. 2. Are you aware of any agent in development ...

No sh-t.

https://www.onclive.com/view/imetelstat-for-lower-risk-mds-data-from-the-imerge-trial Very nice 10 min discussion. Worth listening all the way to the end for clarity on the “extension” study (QT study) which was a back door in for patients who had also also received HMA’s. The QT part of the study (...

Well, looks like John brought in young blood to replace him. (But that shirt!!). Suspect Rosenfeld was of retirement age anyway(of course that hasn’t stopped John from going full bore.). Since you have pointed out Rosenfeld’s penchant for good timing, perhaps his retirement now is a good barometer f...

Have not listened to the conf call yet but PR says interim analysis now moved to first half of 2025 from end of 2024. Enrollment a paltry >40%. Again with the creation of false expectations. Clearly Dr. Scarlett expects to sell the company well before then.

Anil should be paying you a consultants fee.

Kmall, so right. All we have to do is look around. Not that hard to tell, the future is. For example we saw Nvida as gaming was taking off (and now AI), Apple when wireless communication was taking off, Tesla when e cars were taking off, Intuitive Surgical when robotic surgery was taking off. Maybe,...

Kmall, I never knew any of this. Thank you for teaching. I want to think about it for a few days. Many important points. We take the gifts of nature for granted while slowly (and not so slowly) killing it.

youtu.be/drgxkcYrCdY

Sales force hires soon.

Bet she knows Dr. Steensma, the lead author on the JCO article. Bet Dr. Steensma knows her. Bet Dr. Steensma knows Dr. Scarlett and vice versa, too. Dots and breadcrumbs.

Also agree.

If I recall, it didn’t move much despite the huge volume.

Kmall, agree, not an unreasonable number.

RC, Dr. S suggested looking at Luspatercept sales. Once you do multiply by 3 and that’s conservative

Additionally, as you know I look at Geron’s wording very carefully (see multiple “parsing Scarlett” entries). I believe the legal profession has punished Geron’s good intentions enough. When Geron used the wording “in the clinic or in development” to describe that they were unaware of the progress o...

Just a side note. If one looks at the enrollment sizes of various ongoing studies, Geron’s studies are relatively “compact”. It is clear they design studies with an expectation of the kind of strong clinical significance that does not require large numbers of patients to participate. The MF study wi...