Medplay has been posting a lot about a Heather Rosencrans. That has been met with quite a bit of mockery. However, she works for greenleaf, a company whose business is to help companies navigate the regulatory issues and requirements for getting approval from the FDA. It is highly likely ADMD is paying a consultant to help navigate the 510(k) application process. Remeber in an earlier quarterly report they attributed a cost of ~$150,000 to creating the first application. Alot of that was probably for such consultation. Of course anyone getting paid to ensure FDA approval will tell everyone they will get that approval. And given there isn't anything really novel in ADMD's products, I think they will. But the question is how much will it cost. The hourly cost for these consultants is probably between $500 to $1000 dollars an hour. I'm wondering whether these expenses are why we didn't get a report for the previous quarter. Anyway all speculation.
My goodness, you apparently don't know what speculation means. Speculating means the forming of a theory or conjecture without firm evidence. So your capitalized comment about there being no proof, is redundant with my post. By saying I was speculating I was saying the same thing. The only way you can improve your vocabulary is to take the time to look up the 'big' words you don't understand. It can also save you from embarrassment, or potentially much worse signing something you don't understand.
Without any news, I have to admit I'm digging around trying to reassure myself ADMD is a reasonable risk for my investment. So it popped into my mind I could get an idea of how much ADMD knows about the FDA approval process by looking at Cadwell's company approvals. So I went out to the 510(k) database and found that Cadwell Labs has had 49 devices approved under the 510(k) process between 1979 and Jan of this year. Most, but not all of which were approved in the initial 3 month period. So they have experience with applications that sail through and ones that need more input before they are approved. It would nice to know if there were any applications they submitted and never got approved, but if they really sucked at it Cadwell Labs would not have stayed in business for 35 years.
This post in no way claims that ADMD will get FDA approval, it is a sharing of information and opinion. Please do not base an investment decision on this information. Consult your financial advisor before investing in this or any stock :)