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Monday, March 25, 2019 8:41:39 AM
Then I would respectfully suggest that NWBO should not have published the article in the JTM in the first place based upon the import of your argument. What goes for PFS, a primary endpoint, should also apply to survival. So why did they publish the article and focus upon survival? Because they wanted the "good news" implied by the blended results to impact the pps. Unfortunately, the insignificant appreciation did not last long. Further, other investors I know raised questions about the lack of information on PFS. A reasonable interpretation, and that is all we can do, would be that the silence and resort to adjudication wrt PFS, a primary endpoint, signified that there may have been confoundment and the blended results were, accordingly, of concern.
My point is that PFS endpoint achievement is probably not a significant factor regarding RA approvals provided that other evaluative criteria are strongly positive. In fact, it is rather likely, having spoken to an oncologist familiar with immunological approaches, that PFS eventing may happen earlier than would be hoped for in applying the therapy and may even not significantly extend beyond SOC. What is likely to happen is that as the therapy begins to take hold in time and despite eventing, the rate of progression is slowed significantly engendering a concomitant effect upon survival, which, after all, is the "gold standard". The oncologist community knows all about this. Short sighted and superficial Wall Street does not. They rather focus upon Primary endpoints and forces with an agenda, and there are plenty in NWBO's case, accentuate the negatives and their cacophony overwhelms any positive outcome thus placing downward pressure upon the share price. Thus, there is a distinct difference between what is weighted for RA approvals and what will motivate Wall Street. LP and LG may know the regulatory environment quite well and they have brought Innes on to better understand the Wall Street market environment especially given financing requirements and the need to boost share price as alluded to at the ASM. That is all I am saying. JMHO.
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