Roger emails, "Nice call on the approval of Apricus Biosciences' ( APRI) (formally NexMed) Vitaros by Health Canada. I remember reading this article awhile back and you mentioned that it would eventually be approved. I was wondering what you thought of
Back to MELA Sciences ( MELA). Trevor S. asks, "Adam, what kind of timeline are we looking at for the FDA's decision on MelaFind? I know there's no deadline, I'm just looking for a general estimate. Are we looking at days, weeks, months? Any insight would be greatly appreciated. Thanks." Unfortunately, the answer is unknown. A first-quarter 2011 approval decision by FDA seems like a reasonable guess, but a guess is all it is. Unlike drug reviews, the FDA is not bound by any specific deadline for a medical device like MELAFind. This may or may not serve as a relevant precedent, but in August 2004, FDA rejected a pacemaker-like device for depression developed by Cyberonics ( CYBX) that was recommended for approval by an advisory panel two months earlier.
Daniel K. emails, "Back in June, drama surrounded Delcath Systems ( DCTH) and the ASCO presentation. I'm a little fish in a big pond and have only been investing since the market crashed. My question is do I stay married to Delcath through the new drug application and eventual approval decision or run like hell? Thanks for any thoughts."