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dr_lowenstein

02/06/15 4:29 PM

#143963 RE: Hike #143961

LOL LOL of course it is possible. But it is important to remember the history of 505b2. In the past, companies had to repeat everything, including long expensive animal toxicology studies. There was a great outcry about this, from pharma companies, animal rights activists etc. That then evolved into what was then known as paper NDAs. The agency was not completely comfortable with that so 505b2 was codified.
The intent was mainly to allow companies to rely on data for approval not sponsored by them, without a right of reference in certain situations. In practice this has mostly been preclincial studies

I will stipulate that it is POSSIBLE to get approval without efficacy, but it is important to understand that such stipulation is not prime facie evidence that it applies in this case. What is most important is to look for appropriate precedent, but sadly this far no one has been able to supply that precedent
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NASDAQ2020

02/06/15 8:12 PM

#144015 RE: Hike #143961

This discredits disinformation being brought to the board , thanx for sharing.
Elites road has been paved for FDA filing/approval.