CC musings. The back-door strategy
The CC was revealing on two fronts:
1) the 700mg data request is the glide-slope to a Monotherapy indication - label expansion. Clearly, LERO has blown the doors off efficacy and safety end-points. K.Dhody was very concise in his explanation of data availability from the recently wrapped CD03 Trial, which was not available in May at the time of BLA filing. FDA is not asking for more data, just because they can (despite the BP conspiracy theorists arguments here). FDA has asked for the data, because NOW it is available, and it's the most obvious pathway to the label expansion outcome. It won't happen overnight; but expect that label expansion sooner than later.
2) K.Dhody's explanation of the PII M/M endpoint metrics was more meaningful than it appears at first blush. The CC questioner was whining about why CYDY was not using mortality as a primary end-point (like Gilead did), supposing that outcome is better than CYDY's PII primary endpoints. Dhody was surgical in his explanation that mortality as a secondary end-point will be reported, but that the primary end-point (fever, aches, etc...) was the agreed to metric with FDA. A true statement, but what could that mean???
This is where it becomes more meaningful in when combined with other factors:
a) recall, BPatterson has said time and again that the Trial end-points were carefully crafted WITH the FDA, to measure and report data and immunologic outcomes, the SCIENCE (the more difficult and nuanced pathway).
b) while FDA is the primary Trial audience, keep in mind that CYDY will be reporting to a world-wide audience. IF you assume the FDA is a corrupt BP pawn, then you'll want to have taken the harder path, and measure and report actual scientific outcomes. Those results are relevant to parties beyond the FDA (academia, medical practitioners, other governments, etc).
c) Kelly was pretty darn clear regarding the major Partner discussions that are in play for counties outside the grand-old USA. Why? Because you want to sideline the FDA if they are not a willing partner.
I'm guessing that in the PII M/M, LERO will have no difficulty meeting the secondary mortality endpoints. Now, just for a moment assume that it meets and/or blows the door off the more difficult primary end-point outcomes??? Should that occur, I'm theorizing that CYDY has de-risked the FDA, and will take the trial results and will have no difficulty finding a "treatment" partner outside of the USA. Add to that, the PIII Safety Board meeting (which will be reviewing the mortality and safety interim data). Should the PII trial end-points show scientific benefit (besides mortality) and the PIII show good mortality interim data, I'm hedging that the PIII study will be cut short and FDA will be cornered into an EUA. And if the FDA doesn't play ball, then you sign a Partnership outside the USA and start to print $$.
Therein lies the back-door game plan.
Of course, this assumes both the PII and PIII data show results. To that end, I trust Bruce! He knows the science and data and I'll put my faith in what he's seen and what he's currently telling the world...
