Thank you for the subject change , but make sure you are allowed to talk to me among current members of the gg&g e-mail club? I wouldn't want you to get in trouble like Mr. Vitamix8173.
I check in on these medical device boards to see if there is any chatter because I'm a shareholder and want to keep informed. 30-50 people or so doing constant research and due diligence with informative posts is nice but I am looking out for that new info that could have an effect on the share price and learning of it early is certainly an advantage whether to buy more shares or sell some. To me, that is the advantage of being signed up for Biel's e-mails and updates are and what the power of being in a stock group would be. This did not exist here as it was only everything is going great, wave your pom-poms and for that reason I am out.
In regards to De Novo or 510(k) , I get unanswered answers to my questions when I contact the company and conflicting opinions in many of the posts. So to be honest, I don't think Biel or the lawyers or even the FDA knows what pathway Actipatch is on for OTC approval. I believe the lawyers and FDA are presenting arguments still in regards to the pathway and Biel has reported too quickly that it may be leaning to what they want to happen.
So, I don't really know what is in the minds or just 1 mind of the people reviewing Biel's 510(k) submission but my gut feeling is that the FDA's intention with regards to Biel is to delay, delay and delay. From the confusing rules and literature on the FDA website, this certainly can be approved OTC through the 510(k) pathway and Biel IMO has enough to get it done. On the other hand the FDA writes other rules and regulations that allow it to be the reviewers opinion and that reviewer can say De Novo is the correct pathway....and never mind how they define the difference of "Intended Use" and "Indication of Use" which is totally subjective. One would need a very very long shovel to clear all the BS out of the FDA's rules and regulations etc. In Biel's defense they have been fighting the ridiculous rule of Class II or Class III for a very long time especially for the exact same device and frequency and whether or not they say it produces heat or no heat. At least that is behind them but it seems to me the games at the FDA still go on until someone steps in with enough pressure and says enough already. The rest of the world approved this as an OTC device.
