Aug. 9 at 12:15 AM
$PHRRF
In thinking about Pharmather and its FDA candidate KetaRX.... it appears a decision was reached because trading was halted for PHRRF stock today. Most likely it was approved, but I am wondering about this. The FDA requested a minor update to the application, and Pharmather provided it. Being there is a ketamine shortage, and has been since 2018 or so, it is in the interest of the FDA to approve it. Now, this is it. If the FDA thought the minor adjustments were not satisfactory, I'd think they'd much more likely ask for even more data rather than deny registration. Rejection, after receiving a response for a minor adjustment, seems extreme and not in their interest.
That is what I asked AI.
Response summary came to this:
Given the minor nature of required updates, past communications suggest the agency would usually request further data if unsatisfied, rather than issue a flat rejection, especially considering the drug shortage and public health need.
