Imitation Naugahide…
That’s my metaphor for the way DNDN is presenting the data from the 9902a trial to the investment community.
Naugahide is itself imitation leather, so imitation Naugahide is pretty strange stuff—just like DNDN’s analysis.
In this metaphor, the original primary endpoint of 9902a—time to progression—is the leather. Unadjusted survival—which is the primary statistical analysis on a secondary endpoint—is the genuine Naugahide. But, alas, the quality of the genuine Naugahide is suspect, so DNDN has substituted imitation Naugahide: the Cox-adjusted survival, which is a secondary statistical analysis on a secondary endpoint.
I don’t think this game is likely to fly with the FDA and, after seeing the 9902a data, I question whether anyone in a senior position at the Agency actually encouraged DNDN to submit a BLA. (I do not consider the lack of discouragement by the Agency to be tantamount to encouragement.)
If it turns out that DNDN is frosting the characterization of its meeting with the FDA in the same manner that they are frosting the clinical data, things could get ugly for shareholders somewhere down the line.
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.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
