I found this bit the most interesting ;) The meeting discussion...

I found this bit the most interesting

The meeting discussion and minutes provided guidance for an IND submission and for an NDA including the need for a minimum safety database of at least 750 patients. Of particular note, the Agency also suggested some additional studies (not required for product approval) for Phosphagenics to consider, that could potentially enable the TPM® /Oxymorphone patch to gain valuable abuse deterrent label claims.”

I am also aware that an NDA requires thousands of pages of information and an upfront payment in the millions of dollars - $3-$4m I believe (although our status as a small company would generally see that refunded once the application was submitted) ....

IMO a partner is on the cards not only to assist with further costs, studies etc but to also assist administratively with resources in the process of preparation of the NDA .... Still a positive outcome ... obviously the FDA didn't get to speak to playez or this would have been knocked on the head when he demonstrated how useless our TPM is ... lol