My basic thought is: why not do everything possible at the get-go -- even if the company thinks it is overkill -- simply to reduce the risks of delay and another deficiency letter based on human factors?
You would think they would be ready for all contingencies at this point. Question is, can you trust them to be ready?
I brought forward in another post - a current scenario to a company that I follow. Adamis Pharma. They filed the NDA, they were slapped with a CRL, they responded to the CRL and then the FDA slapped them with another CRL. The second CRL due to new questions that came up due to the responses to the first CRL. They have been in a constant - back and forth - with the FDA. They have not had a break in the timeline.
Apricus on the other hand, received the CRL back in 2008. They basically had no dialogue with the FDA for 7+ years, until this last November 2016 ( a type B meeting ). We are led to believe that because of managements expertise in obtaining Vitaros approval in Europe, the FDA will just approve Vitaros on a six month timetable.
Must I remind everybody that the Decentralized procedure was to take 240 days. Apricus filed for approval on April 2011. It didn't receive approval until June 2013. That was 27 months after it was filed. We are not even talking about national approvals at this point.
The reason for the long process, was because of all the times the clock stopped because of questions that came up. Were they successful in responding to the questions? Yes they were.
I ask again, what confidence is there that responses to a CRL dated back to 2008 will produce an approval at the 6 month timeframe? Does Apricus have most of the data it needs to eventually obtain a FDA approval. I want to think that they might. Can you trust the FDA to not ask more questions or request more info at the six month end of review ( if in fact it ends up being this )? I say chances are slim.
You are putting up your money on everything going in Apricus' favor, on a very tight timeline. A timeline that requires shareholder dilution if any hitch happens. What's left to sell? Rayva rights? If there was any meaningful money there, I would think that they would have sold that instead of Vitaros.
Good luck
