To All,
I no longer can even make sense of the negative arguments re HR and P Value.
At first, the argument was that PPHM data was weak or invalid because preliminary data release did not include HR and P value and therefore either PPHM didn't have these ratios or was loathe to publish these results as they were not supportive of the clinical trial.
Now, the HR and the P value have been published and not only are they stat sig but they are outstanding at .52 and .015 respectively.
Faced with this result, the critics have not changed their opinion. Perhaps the critics are stubborn or have other agenda.
Conversely, when appraised of the clinical results under non-disclosure agreement, Oxford, Midcap Financial, and Silicon Valley Bank -three very sophisticated lenders to the biotech industry--lent PPHM US$30mm. (As an aside, the same critics postulated that PPHM would not qualify for signifigant credit and shareholders were facing continual and massive dilution. Neither of which was true.)
I am reminded of the quote describing the great Lord Keynes conversation with a particularly vexious female critic of his work. "When the facts change, I change my opinion Madam. What do you do?" I know if the data had been bad, I would have changed my investment opinion.
Dr. Garnick, when presented with the same data was quoted: "Having personally been involved in the evaluation of over 30 Phase II trials over my career, none of which ever achieved statistical significance, including many of today's blockbuster biotech products, I am personally extremely pleased with the quality of this data and the clarity with respect to advancing bavituximab in Phase III trials, which it provides."
I do note that the critics are responsible for not one drug succeeding at the FDA nor for one dollar of biotech revenue. Dr Garnick is responsible for many tens of billions of dollars of biotech revenue.
The weight of the argument is now so heavily in favor of PPHM that the whole subject becomes tedious. There is not much more value in addressing this particular question.
When I play poker, I try to get my money in with favorable odds.
If I am lucky, I might find situations where the odds are 1.5-1 or 2-1 or 4-1 or at best 10-1. At the current P value the odds of this Phase II study being duplicated favorably in a larger Phase III study of similar design are 98%. I want to get my money in.
Garnick, realizing the odds, wants the study to be almost exactly the same except for the increase in "N". Why wouldn't he?? He uses the key code words "straightforward" and "derisk". Faced with these overwhelmingly favorable odds and the size of the NSCLC market as well as the larger overall potential of bavi ,---"If you were a BP, what would you do Madam????"
IMHO, stay cool, use weakness to further accumulate if you are able, and anticipate further major bullish news.
Best Regards,
RRdog
