Allphase Pharma Consulting, LLC
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We will get to the new Hoberman study[1] in a moment, but first a bit of background. AOM, AECS and AECB were labeled indications for antibiotics in the 80s and 90s but were summarily thrown out from the indication catalogue shortly after the 1998 FDA Guidelines were published. The arguments Continue reading Is the AOM Indication Making a Come-Back?
Just before the November 4th AMDAC on solithromycin, we are being treated to a very fine piece of study write-up. Of course, we are speaking of the File paper on the SOLITAIRE-IV trial, and what a fine piece of crafty penmanship it is, if you haven’t noticed. Just as a Continue reading Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug
There are numerous reasons why drugs get stuck in development. Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well. For instance regulatory issues or manufacturing, difficulties can stop a program. Occasionally, a suboptimal dose was chosen because of (1) incomplete Continue reading Why Some Did Not Make It