Replies to post #147288 on Biotech Values

[porkchop11]

Maybe they have...but not publicly disclosed, or all members of the control group may have passed. In addition, HIPAA may not permit disclosure without pt consent, or is not permitted in the trial protocol.

As I stated on the PPHM board, serious ethical issues may begin to arise or have already arisen. I mean crutch wouldn't you or want your family member to cross-over to the bavi arm regardless of the placebo effect some are alleging? I'm no expert (yea dew I know not even close) but I try to apply some real life logic to situations (actually work in insurance, so have been exposed to certain situations involving rx and off label use as well as contraindications; it's amazing what can get done if you take the right track and/or tact).

So Dew, why don't you give us your honest thoughts about the mos/os development here with bavi, notwithstanding the possible trial protocol questions.

Mimicking apoptosis to avoid detection...beautiful, but its days are numbered! QUOTE THAT!- all rights reserved : ) Oh, and virus' and their little freakin' particles too.

All imo, and tia.

porkchop11

[biomaven0]

This is certainly very strange, given the trial has been unblinded and has no protocol that I know of which would interfere with placebo arm crossover.

If there is no provision in the protocol for crossover, then you can't suddenly start doing so without a modification, which would be a significant fuss.

Generally Phase II oncology trials that are SOC+drug vs SOC don't have a crossover. Companies hate crossovers for obvious reasons (clouds any OS advantage), and such a trial without crossover is perfectly ethical in a situation like this where before the trial there was only very modest evidence that the drug had good efficacy.

In my view most of the PPHM discussion (on both sides) here has been pretty tangential. I for one don't care about some guy's resume - not going to make me buy (or sell) the stock. At the end of the day, it's the OS numbers from this trial that will move the stock in the short/mid-term. The rest is pretty much noise as far as I can tell.

Peter