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Replies to #98653 on Biotech Values
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wallstarb

07/12/10 5:09 PM

#98654 RE: DewDiligence #98653

It does seem disingenous to make an unrealistic expectation seem "very probable" (my term) by implying that the CEO thinks it's likely to submit an NDA for RIDA by mid 2010.

The following wording implies it in his/their opinion was more likely then not to happen, which may have been irresponsible, but to call it a ploy to pump the stock might be a stretch - but it definately smells more then a little self promotional.

"believes that there is a reasonable possibility"

If they said - we expect XYZ to happen in the next few weeks - the stock popped and they raised cash selling into it - then that "promised" event never materialzed then you have a smoking gun. I don't see that as being the case here - just an over zealous CEO over promising and under delivering.

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drbio45

07/12/10 7:22 PM

#98669 RE: DewDiligence #98653

dew,

if the quote below was said by Berger than he is intimating that it was a pretty good chance that they were going to be able ti file based on the second interim. these are pretty strong words.



Based on the current status of enrollment and disease progression events in the Phase 3 SUCCEED trial of ridaforolimus, as well as the statistical power and design of the trial, the Company believes that there is a reasonable possibility that the available clinical data at the time of the second interim analysis of efficacy by the independent Data Safety Monitoring Board would be sufficient to demonstrate a statistically significant difference in the primary endpoint of the trial, progression-free survival, when comparing the ridaforolimus and placebo treated patients