Friday Wrap: USS Peregrine becalmed in the doldrums during the dog days of summer, afloat despite a disastrous blow to its bow while under full sail, fully healed-over, all hands aboard, and all supporters ashore, exhilarated. The cause of the gaping hole in the hull? The smoking gun ashore, or the one OFF-shore? Was it a torpedo or did it originate in the hold? Would the Chinese, with their Cotara news black-out want PPHM bankrupt? Would the Swiss gnomes in Rochetal, Genentec's alpine chateau, be pleased? How about the Russians? We know the Indians would not stoop to industrial sabotage, say, inflating results or mis-staging disease. Inside job? I don't think so. Carlton Johnson, board chairman grumbled, "...until we get to the bottom of this..." And now we have an "internal investigation," a smokescreen or reality. If the FBI, Interpol, and the FDA are all over this thing, it would temporarily be classed "internal". The stuff for a novel...a costly one... fascinating. The seriousness of the situation reminds me of when PPHM almost crashed and burned before being able to move "signal seeking" Bavi trials to India where a few investigators there got a good look at it, and turned in favorable clinical results. Then Russia, and ditto. What's going on?! I held out the following ASM content because is so ...uh...sobering, and also difficult to interpret. Did anyone else get this? Here's a direct transcription from the ASM:
"PII pancreatic ca w gemcitabine
not clear how drug was tracking.
similar results in both [testing sites???]
discordant response in two groups
differences in central read [foreign centers?] vs. local hospitals… put off interpretation
MOS to be reached late this year or early next year. Too early to tell .
Pancreatic: completed enrollment June this year.
Primary endpoint MOS? “WHEN? end of this year or beginning next year
Okay crew. Any ideas? The beginning of the end of FDA-sanctioned foreign trials? Is that what SK was intimating? That there is trouble with the Bavi pancreas trial also? If corners were cut anywhere it was in going offshore for trials. But before the flak starts flying, I'll say management had no choice. The thing nobody here wants to see is that the US trial sites did not show the significant effect for Bavi that the foreign centers did. Anyone else hear this and put it together better than I did? How did I make it through med school taking notes like that?
