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Monday, March 25, 2019 6:16:44 PM
For the last time, I will restate my views on PFS.
1. I do not believe that PFS is pivotal for FDA approval purposes. If other metrics are positive, whether or not the PFS endpoint is met, will not be dispositive wrt RA approval;
2. If upon top line announcement, PFS is missed or ambiguous, it is my opinion that naysayers will claim trial failure and the nefarious forces that we know are out there will keep a lid on the pps and drive it down. We have seen this before when good news has been turned into bad. As before, NWBO will keep its silence so as not to possibly negatively affect its chances for approval. Naysayers will claim that failure in the endpoints will make approval riskier. The overall cacophony of FUD will drown out positive news as the negatives will be accentuated. Continued silence will only add to the downward pressure. LP needs to avoid this possible scenario and she is undoubtedly pulling out all the stops in an attempt to do so.
Bottom line, PFS does not make a critical difference when it comes to approval. However, given market realities and the manipulation that we have obviously seen, PFS, as a primary endpoint, if missed, will IMHO negatively impact the share price. Over and out.
Recent NWBO News
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- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2024 08:13:36 PM
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