Replies to post #45066 on Biotech Values

[poorgradstudent]

DNDN / marko

>And according to the argument advanced by yourself and Dew , the best framework to accomplish this would be a CU program while the confirmatory trial is ongoing , so as not to allow full marketing of drugs that may turn out to have no clinical benefit.<

No, I'm not saying that is a solution. I think the FDA either approves outright and cans 02B, or gives an approvable.

However, I'm not advocating a CU program; I'm simply adding to its discussion and suggesting that it is feasible to implement one if that is a choice. In effect, I don't think it kills 02B enrollment, nor does it bankrupt DNDN.

>A close miss on a survival result is exactly the same thing<

And for the life of me ( :-) ), I don't understand why people don't discuss 02A at all. Was that close? No.

In essence I think we're ignoring the totality of the data. You have two separate trials that gave conflicting outcomes on survival and TTP (or, arguably, conflicting outcomes on survival and two failures in TTP). If that doesn't need a tie-breaker, I don't know what does.

Remember that the general feeling by the knowledgable DNDN longs prior to the AC was that it was going to come down to whether or not the FDA found 02A "supportive". Well, the briefing docs didn't speak highly of 02A, and my impression is that the AC didn't really discuss 02A at all (corrections welcome). So it seems to me there was an elephant in the room, but no one talked about it. In that sense, it almost sounds to me like this AC was a public way of CBER forwarding an agenda in a controlled, public environment.

Again, I haven't listened to the AC or read a transcript, but it is just my impression.

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As for what harm can come about by letting Provenge on the market, I think it is a matter of consistency. If Provenge sets a new standard, then I believe big pharma can flood the market with comparable drugs. The FDA already has trouble enforcing post-marketing trials, and if we leave it to big pharma, they're going to work at a snail's pace, and game their trials however they can (remember pfizer's lipitor trial from a year ago comparing mismatched statin dosages?).

I may not be happy with how the FDA ultimately makes all its decisions, but I trust the FDA to be an objective arbitrer of efficacy much more than big pharma.