Biotech Values

[poorgradstudent]

GNVC:

>I've listened to the CC and every single analyst congratulated the management team on the good/great results.<

No kidding huh? Surprised?

>Both the CEO and Dr. Thornton argued that what is needed is survival at one year, and that the hazard ratio is the key statistic here for the FDA.<

It's also about consistency. GNVC is saying that at 10 months nothing is different (median survival is the same), but then between 10 and 12 months, something incredible happens and the drug kicks in and gives you a great benefit at 12 months. Then it kinda hangs around and gives up at 24 months.

Does that sound like a drug that is consistently doing something?

It might be worth asking when patients receive the last dose of TNFerade. Is it well before the 10 month median survival timepoint? If so, is it reasonable to assume that this adenovirus is still sticking around months past the last injection? I would not think so.

Also recall that this trial allows patients to move onto follow-on therapy such as gemcitabine and tarceva. So you have multiple variables coming into play. It looks to me like TNFerade isn't doing much, patients progress, and then move onto gemzar + tarceva, probably around 6-7 months... so the good performance you see between the median survival time (10 months) and the 12 month timepoint is probably post-TNFerade treatment effects. It appears that the TNFerade arm does better than the other arm, but that's probably noise because by that time, you're dealing with 30 patients in one arm and 15 in the other.