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Friday, March 22, 2019 5:56:07 PM
My point has nothing to do with FDA approval. As I have often averred, I believe that even if the primary/secondary endpoints are missed, with persuasive milestones/long tail etc. achievements, the RAs including FDA will eventually approve.
My point has to do with what happens to share price if these endpoints are missed upon top line announcement. I believe that the market will focus as will the nefarious forces thereto upon the "technical" failure of the trial, and the increased riskiness of approval because of the failure. The market will focus more on the negatives than the positives thus blunting any sustainable rise. There will be disappointment all around adding to downward pressure. Focus will be on needed financings and increased dilution caused by weak share price. The downward spiral is synergistic.
NWBO needs to avoid this scenario. The primary/ secondary endpoints must be met. LP knows this in spades. She is pulling out all the stops including adjudication. Silence on PFS and adjudication seem to suggest concerns on meeting the PFS endpoint. There may not be sufficient separation on OS. These possibilities are not to say that RA approvals are necessarily doomed. I don't think so. But the market reaction will be negative. Investors will need to wait until at least approval for any share price rise and sustainability. JMHO.
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