Hi Doc:
You are confusing approval with share price appreciation. I thought I made it clear: I am, for the record, reasonably certain of ultimate approval, in all 4 jurisdictions applied for, even IF the primary/secondary endpoints of the trial are not achieved.
I do believe that IF one or both endpoints are not achieved upon top line revelation, despite other positive data, the market perception will be that the trial failed(at least technically). Although the "spin"(as averred by the naysayers) pointing to other positive data, importance of long tail in immunological approaches as being the "new" gold standard, etc. will undoubtedly be defensive mode counter-explanations, the market, bolstered by the incessant chorus of the shorts, will otherwise perceive the uncertainty engendered by the failure in achievement of the endpoints as, at best, mixed results thus blunting any explosive rise in the share price. The weightier news, at least insofar as the stock market is concerned, would be the failure of the endpoints. The other positive, and perceived extra curricular, data will be relegated to a second seat in the all important world of perception. The results will not be undeniable and the FUD thereby engendered will register uncertainty, at least where market perception is concerned, and thus weigh upon the share price. The market dislikes uncertainty and NWBO has a long history of that. The risks associated with RA approvals will be heightened.
The better scenario is one where you, Flipper and others are correct about achieving the PFS endpoint as well as OS. Then, there is little to deny by the market. The results will then have met the endpoints and achieved a new gold standard. The share price should then rise significantly and sustainably.
To me, it APPEARS that the PFS(and OS) endpoints are in jeopardy. LP has let the trial continue on and has been rather vague on when data-lock, top-line, etc. will take place. In addition, other than the mention of adjudication, there has otherwise been silence on the primary endpoint. A reasonable assumption may be that these endpoints are in jeopardy according to LP's experts and by letting the trial run longer and being vague in stating timelines, NWBO is doing all it can to salvage these endpoints in the meantime.
In summary, IMHO regulatory approvals will ensue despite failure to achieve one or even both primary/secondary endpoints if the other data is otherwise positive. However, such a circumstance will bode negativity in terms of market perception and the share price upon top line revelation. Hopefully, in this scenario, Mr. Innes will be up to the challenge since the market is his bag. JMHO.
