"Accelerated Approval"... yes it's awfully hard to think AA is on the table when we can't even get FDA approval to spend shareholder money on a p3. We can only hope that Shoulson is hard at work trying to convert a tackle for a loss into a touchdown.
Given that Prana’s Nov 13, 2015 AGM presentation stated they “Anticipate submitting response to FDA in early 2016”, which was followed on April 11, 2016 by “The submission is well advanced, and the Company is committed to ensuring it is comprehensive...”, and it is now August 2016 for a submittal to which the FDA has committed to provide a 30 day response, we have to assume at least one round of submittals was made and found insufficient. Hence presumably being reworked and augmented.
The good news, if we can call it that, is that Prana must not have a final rejection or it would have to be disclosed. So what is the next step? I'm guessing more animal toxicity testing. In which case perhaps something besides dogs, shall we?
I'm voting for primates. From the American Society for Experimental Neuro Therapeutics:
“Large animal models of human CNS disease are most closely approximated in the nonhuman primate. The experimental infrastructure necessary to support such studies and the experimental models themselves require substantial resources and dedicated time and personnel. Yet the benefits in modeling biodistribution and mimicking the anatomical complexity of the human brain and spinal cord may justify such expense.”
Not to mention the benefit of avoiding canine-specific reactions to hydroxyquinolines.
PBT Price at posting:
12.0¢ Sentiment: Hold Disclosure: Held
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