Replies to post #44906 on Biotech Values

[DewDiligence]

>DN-101 results were P2, not pivotal P3s.<

He’s making the same point I made: that the data supporting DNDN’s BLA are more phase-2-like (or perhaps phase-2.5-like) than they are phase-3-like.

If DN-101 ends up showing good results in phase-3, that doesn’t discredit the ODAC view that the phase-2 data package was insufficient.

[poorgradstudent]

gofish:

>Scher's reference to DN-101 may come back to haunt him.<

Having now read the letter, I don't think his comments regarding dn-101 are unreasonable. He's saying that the data for dn-101 to date are not necessarily worse than provenge but that even he, as the principal investigator of the follow-up trial, is saying that the dn-101 data are insufficient for approval.

In that respect, I do think he is being consistent.

>DN-101 results were P2 , not pivotal P3s. I don't know to what extent that implies less reliability.<

The dn-101 trial had a control arm, so I don't think the P2 vs. P3 is a big issue. As we discussed here earlier, DNDN's approval would say that the agency is really worried about there being a control arm in a trial, not whether it is blinded, is a P2, P3 etc...

Also interesting from Scher are the comments about CVAs. I didn't know that the large trials using taxotere (ascent, or the dn-101 trial) had no CVAs. I think he makes a good point that the CVAs in 01 and 02A may be related to the systematic processing of the leukapheresis product. In that sense, suggesting the CVAs in 01 and 02A are no big deal because they are no different than the placebo arm is, justifiably, a false comparison.

The intrigue with this one is approaching IMCL proportions...