P III

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biopearl123
Posts: 189
Joined: Fri Jul 20, 2018 5:13 pm

P III

Post by biopearl123 » Thu Aug 08, 2019 3:14 pm


Gwikley
Posts: 33
Joined: Thu Aug 30, 2018 9:05 pm

Re: P III

Post by Gwikley » Thu Aug 08, 2019 7:17 pm

Finally....lol

Ryan
Posts: 41
Joined: Sat Jul 08, 2017 1:41 pm

Re: P III

Post by Ryan » Sat Aug 10, 2019 9:28 pm

Finally is perhaps the understatement of the century

Future is bright; success of Phase III MDS I peg above 95%.
(Success of the MF FDA regulatory discussions, measured solely by accelerated approval, I’d put at around 45%)

The past decade is full of successes for Imetelstat (and it’s team and collaborators over those years):
- The underlying research led to the Nobel Prize

- The Phase I trial in ET delivered near 100% CRs

- The Pilot study at The Mayo Clinic also delivered breakthrough results with CRs and PRs in a disease that has never had an efficacious therapy, and the famous quote in this preeminent institutions brochure, “Tantamount to a cure in some cases”

- the peer review in the NEJM, the preeminent journal in this industry, supplied the exclamation point to confirm Dr Tefferi’s breakthrough results in the clinic

- Yale has performed and published astounding pre-clinical conclusions as to potential pan-cancer efficacy

-Pre-clinical combo research in AML with Imetelstat and currently approved drug is also, for lack of a better word, astounding. It suggests clinical research with Imetelstat in combo

- Phase II results in both MF and MDS blew it through the roof. Since that summation is not necessarily science speak, I point you to:

- Multiple Phase II collaborators in both MF and MDS have spoke at top conferences and in webcasts to support the further late stage study. One, Dr. Raza, has stated that “when the drug is approved”... when, not if

- The team assembled to shepherd the late stage trial and regulatory affairs for Imetelstat are simply second to none, many with deep experience with Imetelstat

- The CEO has stated the drug “is superior” and “no fear” going into Phase III for MDS

The double whammy of the (opinion - bogus) FDA hold for liver concerns which were proven wrong and the Janssen non-continuation decision, and the stock price sits at prices lower than they were before those events. The market seems twice bitten, three times shy - Up to you to decide whether that is an opportunity.

1bordersooner
Posts: 16
Joined: Thu Jul 26, 2018 5:52 pm

Re: P III

Post by 1bordersooner » Mon Aug 12, 2019 4:05 pm

Nice summation BP :!:

biopearl123
Posts: 189
Joined: Fri Jul 20, 2018 5:13 pm

Re: P III

Post by biopearl123 » Mon Aug 12, 2019 6:24 pm

Thanks 1boardersooner, I can't take credit for that nice summation, it belongs to Ryan, a long time contributor. bp

1bordersooner
Posts: 16
Joined: Thu Jul 26, 2018 5:52 pm

Re: P III

Post by 1bordersooner » Tue Aug 13, 2019 6:56 pm

oops! My bad. However, I do look forward to your contributions.

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