Medplay, Sensi, and Moto = Paid Pumpers!!! Beware!!!!
This company lost all hope of FDA approval with recent news Friday which provided FDA recognition of their radiogel as a Class III medical device. NOT GOOD NEWS!!! Company tried to push this through as Class II in their 510K filing back in November. Now company has impossible task of trying to push through product as a Class III. Multiple reasons why this won't happen by ADMD. First, no financial backing they have will provide enough to get them through the Class III FDA process. Second, they have not done enough research to provide FDA to even come close to Class III status. You will hear paid pumpers claiming the FDA only wants a little more info and "wants to push this through quickly", and how some previous FDA guru, Heather Rosecrans is in the corner of ADMD. ALL FALSE LIES from paid pumpers! Even some of the other pumpers were calling these guys to the table last night asking for links to FACTS concerning this Rosecrans character. Don't waste another dime on this garbage. If you think you can get a few bucks by tracking on a penny or so, go for it. But if you really want a long term investment, steer well clear of this junk. I would advise (and I know I sound like a pumper myself, but your own research will tell you the same) investing in an already approved company like ISR. Check it out and best of luck to ya.
While I posted earlier that they shouldn't of pushed it through as class II, I learned from another investors DD I had not dug deep enough into FDA documents to know that it is perfectly understandable they submitted it as class II. Lastly, you started as a very negative poster, then bragged when you felt your negative posts had single handily lowered the price by a penny as your entry point, After which you were positive. Now your negative again, but I doubt you have sold your investment.
"A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.
(b)Classification. Class I
Oops, the last I was chopped off, the FDA considers radionuclide bracytherapy sources (as described above) as
'(b)Classification. Class II (my copy paste missed the last 'I').
How anyone can read that and still say ADMD was wrong to submit as class II is a mystery to me. Its not my opinion, its not up for debate, this is off the FDA regulation description website. What is up for debate is whether it will be easy for ADMD to expand this definition to include a non-metal or glass enclosure. But the basics of the risk are not much different. Not saying this is a slam dunk, its not. Its a complete gamble, and if you can't wake up and find your entire investment has gone to zero without getting stressed don't jump in now.
I do agree that the FDA could give a crude whether this is approved or not. That is a completely stupid thing to say. Funny how penny stock boards are mostly composed of extreme views, either irrationally positive or negative. But I do find tidbits of useful data here and there. My most useful from this board was a post a few years back to take a look at ELTP. I did and liked what I found. It took two years for that investment to finally kick off. If that lurker is still here, many thanks!