The boxer and the timeline

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

The boxer and the timeline

Post by biopearl123 » Tue Jun 09, 2020 11:12 pm

First off thank you kmall for taking up the challenge of teaching us more about ligand trap and BET therapies. Look forward to your upcoming posts to learn more. Also CKTC, this topic is calling out for your first Imetelchat post! Well Dr. Scarlett has certainly shown us that he is a pro in the ring. He has bobbed and weaved and avoided taking a knock out punch himself while waiting patiently for the opportunity to deliver one. First it was the idea of buying a compatible company, that idea went far far away when Janssen did. Next came the invitation that he would consider ex US licensing. Now with the most recent shareholders call he affirms that he has resources both financial and data driven and its time to deliver a left hook: the criterion for a partner whom if they wish to be considered must be willing to 1. Fund ongoing operations 2. Expand exploration of Imetelstat in multiple indications (a breath of life for the AML study?) 3. Facilitate global commercialization opportunities. That's the KO punch. There is so much to dangle in front of a parter not the least of which is the high likelihood of drug activity in areas barely yet explored e.g. AML PV ET (remember the study showing a reduction in CSCs in MM?). Pretty clear that Dr. Scarlett has not allowed himself to get distracted by these other tantalizing possibilities that could weaken the balance sheet until there is income. So to the time line. There is plenty to crow about at EHA and the following KOL meeting but without a partner there is nothing to bring in additional income. However, Geron's profile should justifiably rise and plenty of BPs will be sniffing around. Dr. Scarlett has probably already presented to many of the big players. Virtually all of the myeloproliferative arena is a large area and if you ain't the lead dog, the view never changes and Geron has indicated that they have reason to believe they will indeed be the lead dog. Someone in the last conf call asked why add 40 MDS new sites? I think (my opinion) is that the original plan was to be fully enrolled by the end of this year with an 18 month timeline from end of enrollment to top line data that could be presented at EHA 2022 (no doubt in a plenary ground breaking session)--I think that was the plan. An inflection point indeed. I think that still is the plan but it can't happen because of the delays we are all familiar with, without more sites and a sprint to the EHA finish line (maybe as a late breaker to buy a little more time for analysis) seems possible. That way European approval might precede the FDA (early 2024 for the latter). By that time the MF study is fully enrolled and maybe the early data analysis available(that part less likely). Failing that there is always AHA 2022. As always critiques of these ideas are welcome. Should be an interesting couple of weeks. Best Regards, bp

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