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Message: Re: Properly powered? What does the FDA think?

My concern with the SSRA and the possibility of needing more patients/events is strictly monetary at this point.  While I do buy into "the longer the better" hypothesis....based on the hope that the event rate in the dosed group is longer......While I do think that POV has merit, I'm more concerned at this point with dollars and cents.

The USD $30 million was just finalized....which looks like more than enough to get us to, at bare minimum, the top line results of BETonMACE.  If the SSRA required the trial to be extended, with more patients and events, then my concern would be.....I think its obvious.  

-We got the loan approved, check.

-The delisting review is done, another check.

-SSRA indicating full steam ahead with no modificatins would be another check.

Get that 3rd check in the box and then, for me anyway, its sit back and when for the trial data....if we achieve the Primay Endpoint I would expect the PPS to do the oppposite of what happened when the primary endpoint was missed back in June 2013.

 

 

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