News that the FDA will not be requiring new trials of Alimera Science’s product lluvien, which is intended to treat diabetic macular edema, seems to bode well for ADMD’s Y-90 RadioGel Brachytherapy device, since both are implantable devices.
The Alimera Science news is significant from two stand points. First, it shows that FDA may be becoming less guarded about signing off on implantable devices. Secondly, the news shows that the FDA can be quick to reverse course, see article on Complete Response Letter for Alimera from this past Oct 21. http://finance.yahoo.com/news/alimera-down-3rd-iluvien-crl-211002291.html.
I will say that I do own shares in ADMD, and believe at current levels I will continue to be a buyer of this stock. I have been watching this stock for over 2 years and believe time and price are right to buy this stock. Once the FDA green lights Radiogel I believe this stock will start to receive more exposure and therefore a high stock price.