How long would a dog neurotoxicity trial take and how expensive would it be? Prana took two years to submit a response to to the FDA where it seems they would have been better off doing the non-clinical trials. Are they afraid that the toxicity trials will fail at the higher doses? Surely if the FDA and the Europeans are requesting this data then it's a no brainer that they need to proceed in this direction. They tried to convince the FDA that the dog trials were not needed but the FDA does not like being told that they are wrong and they stick to their protocols. Shoulson should have known this and their response should have included the information the FDA requested.
As you say with $29M in the bank they have one shot left. So far every decision made by the company has been the wrong decision including setting the wrong primary endpoints for the phase 2 trials. They keep saying they learnt a lot from the phase 2 trials but they keeping missing the point. Shoulson who was supposedly an FDA expert has not added any value to Prana. Do the dog trials and be done with.
PBT Price at posting:
4.8¢ Sentiment: None Disclosure: Held
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