New Company presentation

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biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

New Company presentation

Post by biopearl123 » Mon Jan 13, 2020 9:48 pm

https://s24.q4cdn.com/668523011/files/d ... -FINAL.pdf

A few observation about the new presentation. 1. Emphasis on new class and IP protection to 2033 (they will need it at this rate). 2. New PIII MDS proposals to FDA--this does not rule out a P 4 and suggests this is the desired path. One does not apply for a P4, they apply for a P 3 that may or may not be granted AA status. We have discussed Scarlett's probably strategy in this regard previously. 3. 160 M in the bank 4. Senior management in place 5. Enrollment in MDS study complete by end of year, 40% of sites are enrolling. This suggests the "90" sites mentioned in ASH abstract is a large overestimation of final site count but also suggests enrollment for active centers in demand. 5. New exploratory study for new indication, I submit this will be a front line Rux+imet but some have speculated AML, either is fine by me! 6. For the first time I note that the MF study will likely include an analysis regarding risk of progression to AML, while this has been listed as a secondary end point in clinical trials site, it has only now found its way on to the company presentation slides and could prove very important. My speculation for the year coming: 1. We will be granted AA for MF and the study will suggest a lower risk of AML progression in addition to the already noted symptom improvement, MOS improvement and splenomegaly improvement. 2. The new study will address the need for better front line therapy. 3. PIII MDS will be in demand and data may be available before the mid 2022 primary completion date (median time of onset of drug effect only 8 weeks and primary end point is 8 week TI). 4. The company will need more money, hence more dilution or income from sales if AA granted--that would help a lot. bp

rccola335
Posts: 305
Joined: Sat Sep 28, 2019 10:00 pm

Re: New Company presentation

Post by rccola335 » Mon Jan 13, 2020 11:05 pm

if Imbark is active against MF and not only covering symptoms it should not only be approved for those refractory to Jakafi - should be started with Jakafi or before - you dont wait until someone has one foot in the grave before starting a disease modifying compound

I think they are going for AML like Janssen was - the worse the MDS was the better they responded to Imerge - that dovetails to AML

I was wondering if they would try for AA without saying as much - the FDA process is new to me

This team knows what to do and is following the Janssen blueprint - the CT order is something Janssen was planning and will be interesting to know what it was regarding

Thanks for the info BP

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