Replies to post #26332 on Biotech Values

[io_io]

"...my comments vis-à-vis DNDN have been more reliable than those of one of the other regular posters here"


Well, that one could likely be me, even though I don't post irrelevant (or even relevant) predictions about DNDN. I'll keep this post short.

None of what you have to say has any bearing on the future of DNDN. In biotech-speak you are claiming you see surrogates here-and-there for this-and-that.

The DNDN longs look to the horizon. It will be the FDA that will decide, and not some message-board poster with surrogate theories.

[kcalt]

DNDN >>
Here are some other predictions:

1. DNDN will not in the near future be able to attract a commercialization partner for Provenge on the kinds of terms one would ordinarily expect for a post-phase-3 product in a large medical indication such as prostate cancer.

2. One or more additional senior executives will leave the company before the BLA is approved.

3. DNDN will talk less often about its manufacturing buildout because these plans will be moved to the back burner.

JMHO, FWIW. If I’m wrong, I’ll be the first to admit it.
<<

Dew, even if stratification and small trial size turn out to be a hold up in the regulatory process, I can't believe that the FDA would neglect the largest survival benefit to date (despite the underpowered trials) AND the non-toxic profile.
A confirmatory 9902b, post-marketing might be expected.

I believe that your forecasting ability of this regulatory event will be similar to that of GTCB... And when it does, I will be sure to come back here to toot my own horn like ONE regular poster on this board often does.

[spartex]

http://www.usnews.com/usnews/health/articles/060403/3vaccine.htm

http://pubs.acs.org/cen/business/84/8413bus1.html

DNDN mentioned in both of these cancer articles.