VO2PEAK has been a major feature in our phase 1a&b / Nov 23 Strategy ( A Brainchild of our brilliant minds DrT) A Third Time Opportunity/lucky (1st FTO, 2nd Cardio-protection) brought to DrT 's attention by a shareholder and thank you whoever you are) now we have an expert joining our team.
Vo2peak is the key measurement of Cardiovascular and skeletal muscle oxidative function (please search FDA's guidance of VO2peak) , in our phase 2 trial, Vo2peak will measure and present a clear picture of how bisantrene performance as far as Cardio-protection is concerned, MOST importantly VO2peak allows RAC a path to Accelerated Approval out of Phase 2.
(Accelerated Approval =
A program " that allow for earlier approval of drugs that treat serious conditions and fill unmet medical need based on surrogate endpoint. "
As a norm, the registrational trial is associated with Phase 3 but in our case, Bisantrene can get FDA approval out of phase 2 if we can prove a "surrogate" marker in clinical trial which is based on evidence that Bisantrene can enhance anti cancer effects plus protecting the Hearts by using the best method (vo2peak) convincingly.
In coming phase 1a/b trial (June 24) will have clinical evidence equivalent to normal phase 2 whereby BP will likely make the move (sometimes in 2025/26)
and even better RAC will have enough money (thanks to Bonus / Piggy back options, another Brainchild of our CEO DrT) to run Fast Track Approval Phase 2,
By this time (beginning of phase 2 around second half of 2026) if RAC is still on its own, it would be very expensive for BP to take over and RAC also be in a strong position to negotiate.
DYOR
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VO2PEAK has been a major feature in our phase 1a&b / Nov 23...
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