What you don't see...

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Joined: Fri Jul 20, 2018 5:13 pm

What you don't see...

Post by biopearl123 » Fri May 15, 2020 8:03 pm

What we don't see is in looking over the general categories of competition for Imetelstat in both MF isn MDS is: wait for it-- not much. In MF there is Rux but presentations at EHA seem to lean toward Rux withdrawal syndrome or the increased incidence of secondary malignancies. Yes there is interferon but it looks to me like this therapy is targeting higher risk patients with lots of side effects. So short of a bone marrow transplant with its high mortality, high risk but long term efficacy I am not seeing much else in the MF arena. For MDS especially in low risk, Lus targets the ringed sideroblast group with is about 15% of MDS. Leaving aside the non5delq group (lenolidimide approved), the vast majority of patients will be the potential market for Imetelstat. The durability of Lus is going to be challenged anyway and Lus failures (some percentage of the 15%) will eventually provide more patients. For high risk MPD patients and AML there is a crying need for therapy and it is a crying shame that the AML project must be postponed. What we do see is the good news is that the data is quite good in both MF and MDS. My view is that the FDA should approve on the basis of the existing data in MF but what is more likely is outright approval in TN group and some phase IV for the rest. Re MDS, I have discussed the risk to the nations blood supply from COVID 19. The data in part one is stunning. While we can only guess what the enrollment in part II is, perhaps the scales will fall from the eyes of the FDA and they will allow a look at the currently enrolled population. Its pretty clear to me that the current study design with a primary end point of 8 week TI (a low bar for this drug) could allow for the study to be stopped early for efficacy. We are finally seeing very good news after waiting a very long time. In a way for those who actually have been able to wait it out, the perfect storm of the Janssen departure and the effects of the virus on the market did allow for remarkable buying opportunities and a very enhanced company valuation with the assumption of full ownership, no debt and excellent evolving data (which Janssen could not have known about because it did not yet exist.). The honor of an oral presentation at EHA is not to be underestimated as there are very few and this data stands alone and it appears, continues to get better. Be well, stay healthy and best regards, bp

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Joined: Tue Apr 12, 2016 1:55 am

Re: What you don't see...

Post by tutt » Sat May 16, 2020 3:54 pm

Thanks BP, a great summary and assessment.
After so many years, the science tells a very encouraging tale.

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