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Biotech / Medical : TTPH, Tetraphase Pharmaceuticals
TTPH 2.200-3.5%Jul 28 5:00 PM EST
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To: scaram(o)uche who wrote (25)5/19/2016 4:36:07 PM
From: HardToFind  Read Replies (1) of 80
 
>> I feel that the chances are slim and none. <<

I agreed with the "chances are slim to none" assessment for two reasons:
  1. The FDA (and the scientific community in general) are not keen on allowing the use of data gathered to prove one thesis, to retroactively prove a new thesis. It opens the door to "data mining", or picking through data to find anomalies that support your interests. Allowing it greatly increases the probability of coming to false conclusions, and the FDA shouldn't want to open that door to TTPH or others.
  2. There was likely less data that would conform to testing of the new hypothesis, seemingly yielding a lower level of confidence.
As bad as it feels for TTPH, a new study was seemingly warranted.

Seems like three eravacycline studies are now in the works:
  1. New cIAI (intra-abdominal) twice-daily, for an initial NDA. As you said, it seems nearly the same as the IGNITE1 trial. (TTPH is working with the FDA on details.)
  2. New cUTI (urinary tract) once-daily IV to support a supplemental NDA. (TTPH is working with the FDA on details.)
  3. An early clinical study on oral dosing. (I think it goes without saying that without an oral dosing capability, this drug isn't all that special. Said another way, the ability to transition to oral dosing will drive considerable demand as a cost savings for treatment.) This study is scheduled to start in Q2 (perhaps has started already?), and findings should help advance the oral development program for eravacycline toward a new Phase III (probably in 2017?). I sort of presume this is a non-human study...does anybody know if that is correct?
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