All of the reputable analyst are saying buy. Read the CRL yourself. The most important issues to launching a new drug. The company has a facility ready to produce. The FDA doesn't require futher clinical trials. As to management, the requested items are new. The request to divide the two groups are from an ASCO 2011 guide. This company's study was already completed before the guide was released and shouldn't be relevant. The issue with the Human factors study is new. It wasn't in the first CRL. It's an add on.
Sentiment: Strong Buy
If the FDA states they will conduct a Class 1 review after APPA submits their response, I think that will be the starting point at which everyone will look back and say, geez, I wished I'd gotten in there. Most investors are not aware of back burners APF112, APF580, etc.
Everyone can relate to how nice it is to take sustained release medication each day, but I don't think most people can comprehend the advantage of taking sustained release medication once a week, or potentially, with some applications, once a month.
I speculate this could probably be applied to hormone medications as well. Maybe even more importantly, it might be applicable to mental health medications, specifically bi-polar. Hundreds of in vivo successes??? Wonder what they all are. We won't know until they start collecting revenue on APF530. It is the proverbial keystone.