ImetelChat

BP, thank you for addressing my questions. I continue to digest your summary, and I think I’m getting there. The shear length of the trial in completing enrollment coupled with extension in the interim and final analysis dates throwing a few curve balls suggests the BAT has improved and helped both ...

As I have stated before, much of the discussion has been difficult to digest and understand, but still very interesting. It seems the board has explained Geron has gone to great lengths to design the trial for undisputable results and have set a high bar for an interim analysis that halts the trial ...

Although much of the recent analysis and commentary is over my head, from what I have been able to glean is that from the way the trial was designed, at this point in time there is a high probability that at the interim analysis cut-off of 112 deaths, the trial will be halted for meeting the CT’s ...

I hate to admit it, but these discussions are making me dizzy. It seems the Dr. K abstract of analysis protocols and RWD results is comparing apples and oranges with the IMET MF P2 results and IMpact P3 CT design.

Do you go to these events to present bad results?

Appreciate that. Only time will tell us the answer.

It seems to me the modeling is more deterministic in nature, outcomes based on defined inputs. If so, can the modeling incorporate randomness with the various inputs to simulate a range of outcomes and probabilities, i.e., Monte Carlo simulation with thousands of simulation runs? This thread of ...

BP, I'm pulling for that outcome, but for this to happen, doesn't DSMB have vote to stop the trial to then allow Geron access to the data?

And Dr. Feller too, but Geron has to have access to the data and the only way it seems is for DSMB to be satisfied with interim data, not necessarily halting the trial, but to unblind the results to Geron. Maybe Geron would want to continue the study while seeking NDA approval.

BP, I would love for interim results to warrant an NDA filing and FDA approval to market with the trial continuing as a P4 to do as you say "emphasize longevity".

If their restructuring and employee reduction costs hit mostly in Q4, that would make sense of their increased sales growth offset by ...

BP, You were able make sense of my question and clarified my understanding of the trial analysis protocols. Nonetheless, I think the results will speak for themselves and across-over patients OS will stand out.

BP,
In your reply to KT, "......the design of the PIII MF longevity study allows for crossover from the BAT group to treatment which would “dilute” the primary end point....", in addition to projecting what it would have been like had the patient(s) not crossed-over, it would seem the converse could ...

I agree, presentation confusing. To me, net product revenue suggests product sales less non-company costs related to the sale of the product. Non-company costs would include product purchase costs, transportation, warehousing and distribution.

Operating expenses would include employee related ...

A real head scratcher on a number of fronts. Hopefully more to come. While Geron is now under a new management team, previous management hyped this trial and the previous single agent CT to get to IMagine, now crickets.

From FDA Clinical Trials website, this trial looks to be a long one to wait for at some 54 months for primary completion.

Understood that advances in non-IMET related therapies, BAT, may be contributing to control arm OS improvement and the general benefits of just being in a study contribute to patient improvement, but how will the trial assessment account for improvement due to BAT as opposed to many trials where the ...

I can't speak to Big Pharma trying to stop telomerase inhibition research and Geron, but the Hedge Funds and other sophisticated traders, with their trading algorithms, can and have been short selling Geron for a few years now. This will continue as long and until Geron can deliver, forcing the HFs ...

Wishful thinking, but as much as Geron has touted IMET for MF against RWD on other BAT the last couple of years.......
However, should Interim results in mid-2026 not deliver a knock out punch, maybe RWD in a NDA could get Geron over the finish line. To me, another 2 years to complete P3 to enable ...

Any positive impact to Geron with FDA announcement today allowing RWD to be included in NDA submittals?

I'm pulling for increasing sales to be the caae.