"One problem with MCU/MPH's timeline is..." "results at the end of August or beginning of September of '08.
Management stated in the Jan/12 CC that they anticipated the release of MEND II clinical data at the end of 1st qtr 2008 and submission of an NDA in June/08. Most Phase III trials take 3yrs. MCU started enrollment in Nov/06 and anticipates submission of an NDA in Jun/08, 18 months.
"The FDA Fast Track status means the FDA instead of taking 9-12 months to analyse the data submitted will take no more than 6"
Fast track status has nothing to do with an expedited review process once the NDA is submitted unless the FDA has also granted them priority review.
"My hangup with the company right now is that since the PH2 results were released everything else (all other drug trials)were put on hold while Ph3 has been set up so we've lost over a year on everything else moving forward. That's the worst Management strategy I've ever seen."
How anyone can say this is the worse management strategy is beyond me. Your timelines may prove to be true, but I don't see a reason to second guess. As far as everything else on hold. In case you forget, AGGRASTAT was a significant corporate development.
The company has made huge strides, all small bio_techs run into delays during their clinical development process due to financial constraints and overly optimistic timelines.
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