ImetelChat

The key part of this hire is that he's a Novartis alumni. Quite the stacked deck in the C Suite for an acquisition that really would upend the power dynamic between Novartis and Incyte.

Great find Ryan. I agree, we need this kind of investor engagement!

This is a sobering timeline. How much worse does it get if they must go all the way to the final analysis in 2028? My guess is that without all the accelerated aspects triggered by early cessation due to efficacy we won’t get FDA approval until 2030 or 2031. I think that further strengthens the case ...

“ But what it does indicate is that if you evaluate the facts that Claude evaluated, your conclusion would probabaly be similar to Claudes.”

This is the crux I believe. Thank you MG for all the work you put into this. I don’t see any less value in what you have built than in taking the advice of ...

Wonderful analysis. Remind me though if it captures the positive effect of all the real world numbers being from a world class cancer center with a high level of expertise in hematology? If memory serves me, this is a worldwide trial and certainly the level of care in some areas of the world is ...

Bravo MG.

FYI, I'm not trying to soft bash or be subtle. I'm trying to understand how quickly doctors will adopt Rytelo when it is approved for MF. If the market penetration is anything like MDS then we would have a problem.

If hematologists who are used to managing RUX have a patient who stops responding I ...

Hi BP, how does this differ from the ongoing conversations that we have been having? This information has been out for weeks and pretty thoroughly discussed here and elsewhere I thought. Am I missing something?

It does make you wonder though how urgent hematologists will feel the need is for Imetelstat if they can simply follow Moffet's BAT and see such impressive mOS. Keeping in mind that Rytelo is an expensive drug it may come to pass that Rytelo is used as a salvage treatment for many years before ...

From Seeking Alpha:

...in December of 2024 the company was projecting this: "The planned interim analysis is expected in early 2026 and final analysis in early 2027". How does that factor into the analysis? By that date, 262 patients were already actively enrolled in the trial. We seemed to have ...

Thank you. So how does this analysis of the deaths alter any previous understanding of the statistics at interim?

Patients in both arms? Has that changed your opinion of the interim analysis?

From the looks of the ASCO poster, Geron is having significant difficulty recruiting patients to take Imetelstat in combo with Ruxolitinib:

"The enrollment of the first patient in was on January 10, 2025. As of April 2026, Phase 1b
has 3 patients enrolled in Cohort A and 6 patients enrolled in ...

Please remind me, if BAT has an mOS of 26 months does the model still suggest that the interim analysis favors ending the trial early for efficacy?

I wonder if the clinician explains the consequences to the BAT patient. It would be nice to know that in the interest of expediting approval of a potentially life saving drug that these patients opt for complete withdrawal from the trial.

Please then ask if these statistical corrections will occur at interim or if they are only relevant at trial completion. Also, is it valid to assume that discontinuation could explain the continued pushing back of the interim analysis?

I would like to add a final wrinkle to our discussion. We know that crossover was designed into the trial because it is morally and ethically important to allow patients to get access to Rytelo if their clinician thinks that the patient will benefit. We also know now that the effect of such ...

This inclusion criteria for IMpactMF leaves little room for ‘healthier’ patients to sneak in and disrupt the data.

Inclusion Criteria:

Diagnosis of primary myelofibrosis according to the revised World Health Organization criteria or post-essential thrombocythemia-MF or post-polycythemia vera-MF ...

“…there may be some era effect from earlier rux discontinuation producing healthier patients at enrollment —”

I don’t understand this statement at all. The enrollment criteria and the definition of Intermediate 2 are scientifically established. A patient ‘healthier’ than Intermediate 2 is by ...

“This may affect both arms in a similar fashion, we shall see.”

Of course the problem with this statement is that if both arms see improvement in mOS then we will not have enough divergence at the interim analysis.

Can someone please explain to me though why earlier discontinuation from RUX could ...