Significant is in the eyes of the beholder.
Some thought yesterday’s PR was significant, others did not.
I think the Company’s investment of scarce funding and scarce management time to launch multiple clinical programs in multiple continents is very strong evidence of their knowledge they are sitting on a block buster. Overseas clinical trials of Bavi would give the Company a “significant” advantage in three respects:
(1) a big head start in designing US Bavi protocols;
(2) a big boost to the pps through a flood of clinical cancer data many months before that data would emerge in the U.S.; and
(3) much more leverage in negotiating with BP next spring from having treated many more patients. I laid out my thinking on the BP negotiating advantage in a post several weeks ago which is paraphrased below.
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“Most small biotechs would be forced to strike a BP alliance on the eve of starting large and expensive Phase II trials, especially if the drug were limited to the oncology market where US trials are so slow.
“The problem is that you can’t increase your bargaining leverage with BP (i.e. by threatening to do the Ph II yourself) unless you’ve already put an extra $40 million in the bank. Threatening to raise the capital with your favorite banker doesn’t cut it. But once you’ve suffered the dilution and raised the Ph II capital, you’re kind of locked into conducting the Ph II yourself.
“I believe PPHM is laying the groundwork for trials in places like India, Eastern Europe and China because the “cost vs. BP negotiating-benefit” of rapid, inexpensive trials in those regions is very favorable as compared with the “cost vs. BP negotiating-benefit” of comparable trials in the US. From what I’ve heard you could do high-quality Ph 1B or Ph II clinical trials on an additional 120 patients in those three regions (40 in each region) in less than six months and for half the US cost. I’m guessing these foreign clinical trials will start in the fall and finish in the late spring.
“I expect that when PPHM sits down to play cards with BP in June 2007, the hand they play from will include efficacy data from over 200 world-wide Bavi patients.”
