An 'intermediate' response from the FDA. Out of the three classes of medical devices, I think it was pretty obvious that if anything, it would be considered a class III. Class I would be a bandage or splint, Class II would a wheelchair or stretcher for example. Class III would be like a pacemaker or stint type devices, etc. Because of the invasiveness and life altering potential of AMIC's product, it could be only classified as a Class III device. I see this as a big step forward. Remember anything other than a denial by FDA is seen as a positive. I am taking the glass half full point of view. To see our product fly unimpeded through the FDA process was being too optimistic. I think the FDA likes what it sees, and likes the potential that the product has, but it also wants AMIC, like everyone else, to go through the necessary, regulatory process. Again what may be perceived as common or ordinary news to some, is perceived as good, and expected news by others. You can bash or acknowledge and appreciate. MDLAND~
One post you think its good news the next post you and your fellow Stooges think its bad news. You idiots have no clue what you are talking about. How many times have posters here told you jackasses to shut up and wait.
I wholy agree moto. As we had posted before, anything but a denial is a good positive. The guidance is clear. ADMD works within that guidance and it should find approval. The timeline is still summer to fall for RadioGel so I think the company is right on track! Cool.
I also think that the negative nancies will not get it. They will not be able to wait and will sell. Look for a good share price next week to buy and expand the position.
Sentiment: Strong Buy
Very positive response from FDA, only a short time before this is approved. Not worried whether it's classified as a II or III, but that it wasn't denied. Once approved, automatic revenue generation. I'll continued to add to my position, time is on my side.
Medplay01, I agree. The fact that it wasn't denied is seen as a positive. Not just by (some of) us, but by potential investors and the medical community. Hopefully we can start to get some more 'quiet accumulation'. Again, to expect a walk through, in the FDA process of approving a Class III device by a micro cap like AMIC would be unheard of. Again, we're not trying invent a new bandaid, this process is going to take at least one, if not two more steps. Perhaps now, folks are starting to believe, and we can get some financial backing, i.e., grants or investment partners. MDLAND~
This statement near the end of the P.R. is interesting. Possible future, Merger? Takeover? Buyout?
"The Company intends to outsource material aspects of manufacturing, distribution, sales and marketing for its products in the United States and to enter into licensing arrangements outside of the United States, though the Company will evaluate its alternatives before finalizing its plans". Kind of an 'open' statement, though not interpreted by me as negative. MDLAND~
The fact that our device is considered as Class III was expected, but that also means a bigger hill to climb for regulatory approval. Hence, the reason AMIC wants to reclassify as Class II. Good luck with that though. This device isn't exactly an inert device made of glass, wood and steel. Class III approval is much more stringent, detailed, and as a result, more costly than Class I or II approval. We could be in for more wait time folks. MDLAND~