like i said boiler, some of what you actually post is informative, and i'm not going to try and defend the statement that recruitment would be complete by Q3-4 2013 (i.e. now).
if you want me to speculate, it could be either of, none of, or a combination of:
- martin rogers lying (bending the truth) to ramp the company
- problems with recruitment, you need to be very specific on the selection criteria
- refining of the protocol which put a delay on recruitment
- phase 2b trial going longer than expected
- delays in ethical approval from certain sites
- who knows what else.
regarding the phase II/III scenario, my personal opinion on this is the following:
the FDA usually want 2 successful phase III trials before approving a drug. that means two lots of data that satisfy phase III criteria.
So, this would be the first trial that is investigating phase III data, while also completing any remaining data collection necessary for phase II (placebo arm).
if this is the case, and i am only speculating, then of course time to market is a lot longer than people might anticipate (especially on here). but if results are promising, then there is a still a profit to be made between now and then....
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like i said boiler, some of what you actually post is...
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