These are details as to how practitioners will effectively deliver the drug. If the FDA is requesting this, then it is approved and the details are in the practitioner delivery concerns. These doctors are in fact "doctors". I don't think the delivery is so complicated, but perhaps they want to get it right. I like it and it's a great sign for longs.
phase III was conducted with a "larger" needle inserter for the drug.after approval they intend to use the "smaller" needle inserter....that's what i read in my dd.reason for this study is not to have a delay...smart.JMHO
I just read the 8-K from ALIM. It's all about streamlining the process. Eye doctors do this all the time, even with Avastin; a drug "NOT" approved for this indication. The FDA is covering it's bases. They realize that this "Will" be used frequently and want to make sure they "the doctors" have it under control. My one question is: Why does ALIM wait until now about the request by the FDA in September? Sure could have used it then, The stock should move in a good way, as this is real positive.