Replies to post #25620 on Biotech Values

[DewDiligence]

>Dew, any thoughts on what DNDN is doing as a strategy with their P-11 trial as it relates to FDA BLA filing and review for approval? See this post by eagleeye (yahoo dndn MB); some interesting thoughts on what could possibly play out:
“IMO, DNDN is purposefully waiting so that it can go for the whole enchilada early next year.” <

That post by eagleeye is BS. P-11 is a non-registrational study.

[poorgradstudent]

Bottom line with P-11:

Even the company can't articulate what is expected from p-11 with respect to efficacy.

That should tell investors all they need to know regarding the potential impact of this trial on ADPC treatment strategies.

At the risk of alerting the hypothesis police, p-11 is just that... hypothesis generating.

[iwfal]

Another thought is that if DNDN includes p-11 efficacy data and that data is good, then IMPACT becomes utterly meaningless. I think the FDA could tell DNDN to scrap IMPACT if p-11 is good. That could be another reason why DNDN is submitting p-11 efficacy. Scrapping IMPACT would save DNDN a lot of money for sure.

EagleEye is a nice guy but has a long history of completely unrealistic expectations. Look back a little over a year for what he was saying about NDA filing, ... . Also note that he does not understand anything at all about how drug trials work - e.g. saying that the FDA would "tell DNDN to scrap IMPACT if P-11 is good".