Ritz: your point about only 28 mTNBC patients in t
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Posted On: 03/31/2025 7:48:43 PM
Ritz: your point about only 28 mTNBC patients in the trial is very well taken. Actually, we would probably only be looking at the 21 of 28 who responded to LL with lower CTCs. But if 5 to 8 of that group are still alive and cancer free, that would be between roughly 25 and 40 percent of the responders. Given how deadly mTNBC is as an unmet medical need, and how safe LL is, having a 25 to 40 percent chance to survive and thrive would seem like a no brainer to me, especially with requiring a follow up confirmatory study.
Also, I would think that the European Medicines Agency (EMA), which also has accelerated or conditional approval authority, would be a viable alternative to the FDA for this purpose. Bear in mind that GSK and MRK are well acquainted navigating those regulatory waters.
I may well be in left field here, but reading the wording of the accelerated approval provisions, the wording of the shareholder letter, and the primary nature of the audience at the 2 European cancer conferences, if an oncology partnership and accelerated approval are not in play, they ought to be.
PS. Let me also correct that Vienna, not Berlin will be the location of the upcoming July 7-8 cancer conference.
Also, I would think that the European Medicines Agency (EMA), which also has accelerated or conditional approval authority, would be a viable alternative to the FDA for this purpose. Bear in mind that GSK and MRK are well acquainted navigating those regulatory waters.
I may well be in left field here, but reading the wording of the accelerated approval provisions, the wording of the shareholder letter, and the primary nature of the audience at the 2 European cancer conferences, if an oncology partnership and accelerated approval are not in play, they ought to be.
PS. Let me also correct that Vienna, not Berlin will be the location of the upcoming July 7-8 cancer conference.
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