Marzan:
Thanks for the civil post. I believe you have stated a number of misconceptions.
First, I have never said that mPFS and mOS are primary and secondary endpoints. If you read my posts carefully you will note that I rather refer to them as PFS and OS respectively.
Insofar as PFS is concerned, it has been used as a surrogate for OS because a strong correlation was demonstrated between PFS and OS. In order to shorten the length and expense of a trial, PFS was used as a surrogate to OS. PFS or progression free survival means that the disease does not progress, i.e., the tumour does not enlarge. The tumour need not shrink, all it needs to do is stop growing larger. The confoundment with PFS in the current trial has to do with enlargement of the tumour. The question is whether it has grown because the disease has not been arrested or is due to the ameliorative effects of the vaccine causing enlargement due to inflammation. This has been hard to detect/confirm in earlier patient scan studies but has improved over the years. The facts that NWBO has been silent on the PFS blended data and the need for adjudication suggest but do not necessarily confirm that the achievement of the PFS endpoint, a 4 month delta vis-a-vis control, is in jeopardy. That said, regardless of whether PFS is now considered a less appropriate endpoint for immunological therapies, the fact is that PFS is never-the-less a PRIMARY endpoint.
IF top line revelation shows that this endpoint has not been achieved, the market will note this failure and assume that approval may be in jeopardy. At the very least, the risk associated with approval has been enhanced as a result of this failure. Thus, this likely market perception may rather give undue weight to this failure and gloss over or even ignore countervailing positive data as extra-curricular and of questionable consequence. This is especially true of shorts and hedge fund manipulators who will run their propaganda machines 24/7 and exploit the various shortcomings (pun intended) of the announced results. This will put a lid on the upward momentum of share price and possibly deflate the price because of unrealised but rather dashed expectations. We have seen a precursor of this when the very favourable JTM article was published and had relatively negligible effect upon the stock price. If the manipulators could do it then, they will certainly re-double their efforts with top line unveiling especially if an important endpoint in the trial protocol has not been achieved. That is why LP is pulling out all the stops and doing all she can to eliminate or at least mitigate a less than successful result in these endpoints. Accordingly, LP is in no rush to data-lock, has been vague about time-lines and is otherwise playing for time to cover all the bases as best she can.
I must emphasise that even IF these aforementioned endpoints are not met it does not necessarily mean that NWBO won't obtain regulatory approvals with other very positive data. But failure to achieve trial protocol endpoints may have a deleterious consequence insofar as share price is concerned.
The announcement of top line is a seminal event and significant chance to raise the share price as one of the directors alluded to at the ASM. Missing endpoints could deal a devastating blow to sustainable share price appreciation which will be necessary in financing NWBO's future needs, lest it falls prey again to toxicity and the ensuing side effect of continued dilution. JMHO.
Marzan, may I proffer a bit of advice? I respect well argued views that may conflict with my own. I am admittedly not the sharpest scalpel in the operating theatre and I can learn from opposing views. Hopefully I can then become a better investor. Yes men, always agreeing with my position, are a bane to my existence. JMHO.
Still friends Marzan?
