Perspective on the MF field

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cheng_ho
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Perspective on the MF field

Post by cheng_ho » Tue Feb 25, 2020 4:49 pm

MF is a lot smaller market... but there are still many current trials, some of them even combo trials.

https://clinicaltrials.gov/ct2/results? ... ity=&dist=

Gwikley
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Re: Perspective on the MF field

Post by Gwikley » Sat Feb 29, 2020 3:27 am

FWIW: IMO.....Ultimately I believe that it was for these very reasons that JnJ decided to withdraw. The "Billion dollar pipeline: that they touted at their press conferences regarding the potential revenue stream for Imetestat, was, apparently, grossly miscalculated. And the "competing" trials, directed at the same disease, were numerous then, and have only increased in number. Cost to them for the "mistake": 65M+

rccola335
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Re: Perspective on the MF field

Post by rccola335 » Sat Feb 29, 2020 5:09 pm

i think they bailed due to the italian paper on MOS - when it came out there was no chance to refute it or prove it and thus they didn't feel comfortable in committing up to a billion dollars to continue - that killed the deal - the FDA must think there is something here to grant fast track after looking at the italian study and real world data put together by Geron - we will see

biopearl123
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Re: Perspective on the MF field

Post by biopearl123 » Sat Feb 29, 2020 6:26 pm

rccola335, the Italian study on MOS certainly raised an eyebrow, but the FDA in looking at RWD would probably take a magnifying glass to the actual statistical analysis such as looking carefully at age/disease matched controls to be sure the comparisons are valid between the treatment group and the "control arm" such as it is. For example, in order to get into the R/R study very strict entry criterion were required. Not sure that the same definitions applied to the patients in the Italian study group. Would be a good question for Scarlett but he won't answer it now but might at the May shareholders meeting. bp

biopearl123
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Re: Perspective on the MF field

Post by biopearl123 » Sat Feb 29, 2020 6:31 pm

Bill, thank you for your contributions as always. One thing about the ongoing studies you cite and there are many listed, have you seen any that suggest actual disease modification? Even the last Abbvie Venetoclax study update released yesterday in AML did not statistically prolong life even though it showed CRs etc. The ASH study in mice did suggest eradication of some AML cell lines with Imetelstat/Venetoclax in combination giving hope to the possibility that the "new" exploratory study will be in AML.

rccola335
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Re: Perspective on the MF field

Post by rccola335 » Sun Mar 01, 2020 12:55 am

Scarlett never addressed why JNJ was looking for a pricing manager for imetelstat for AML in addition to MDS and MF - that came out of nowhere - I would like to go to the shareholders meeting to ask him that question - was it a surprise to him or was he aware they were working on something? I am sure the people who came over from Janssen know what it was about.

cheng_ho
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Re: Perspective on the MF field

Post by cheng_ho » Mon Mar 02, 2020 4:38 pm

rccola335 wrote:
Sat Feb 29, 2020 5:09 pm
i think they bailed due to the italian paper on MOS - when it came out there was no chance to refute it or prove it and thus they didn't feel comfortable in committing up to a billion dollars to continue - that killed the deal - the FDA must think there is something here to grant fast track after looking at the italian study and real world data put together by Geron - we will see
The Italian paper certainly didn't help. Nor did Tefferi saying at the summer Italian conference that "I don't like any drugs in trials for MF".

JNJ also has access to preclinicals that we don't... they never got enthused about venetoclax/imet, and the recent ABBV failure proves JNJ was right.

cheng_ho
Posts: 137
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Re: Perspective on the MF field

Post by cheng_ho » Mon Mar 02, 2020 8:27 pm

rccola335 wrote:
Sun Mar 01, 2020 12:55 am
Scarlett never addressed why JNJ was looking for a pricing manager for imetelstat for AML in addition to MDS and MF - that came out of nowhere - I would like to go to the shareholders meeting to ask him that question - was it a surprise to him or was he aware they were working on something? I am sure the people who came over from Janssen know what it was about.
Scarlett had promised an "AML trial in 2016", so it's not surprising that they were looking at AML in 2018. AML is just what happens when you don't have effective MDS treatments, after all.

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