Wednesday, June 16, 2010 11:49:03 PM
Your motives notwithstanding, if those are the two possible reasons the FDA requested an electronic copy, then you have to look at the full context of the request to reach the most likely conclusion. First, the request for the PDF copy of the DViS 510(k) application was made at the same time the FDA asked for 2 minor changes to the language in the DViS manual. We know they were minor because they were made by telephone, and the FDA's website explains that only the most minor requests, such as language changes to a label (the actual example given by the FDA), may be made by telephone. Do those two minor requests for language changes suggest the FDA was gearing up for a major third party consultation about the application? It doesn't to me. Second, we have also heard that since the time of the request for the PDF copy, Dean has contacted the FDA multiple times and each time has been told by the FDA they have everything they need and are just running everything through their process. Doesn't sound to me like some major additional review by new parties is going on in the background. Finally, it's not just that the FDA asked for an electronic copy... THEY ALREADY HAD AN ELECTRONIC COPY! Dean said the submissions are made by hard copy and electronic copy. The late April request from the FDA was not for AN ELECTRONIC COPY, it was specifically for a PDF electronic copy, to supplement the already provided Word version of the application... a version that could be shared with other government or third party entities for simultaneous review, redlined, edited, supplemented, cut and pasted, etc. Instead, they asked for a PDF version... a version that could not be edited, could not be cut and pasted to other entities for simultaneous review, a version that could be loaded onto the FDA's website and remain unchanged forever.
In other words, if you look at the whole picture, and the language from the FDA's website, that's why I reached the conclusion that I reached. But I encourage you to continue to cast doubt and try to turn this obviously good news into bad... after all, it's just your life's savings.
FEATURED North Bay Resources Announces Federal (MSHA) Approval of Mt. Vernon Gold Mine Operational Plan and Commencement of Production, Sierra County, California • Oct 21, 2024 9:00 AM
Hydromer, Inc. Announces the Restructuring and Formation of World-Class Research and Development Division to Drive Innovation and New Product Development • HYDI • Oct 21, 2024 9:00 AM
SANUWAVE Announces Reverse Stock Split, Note and Warrant Exchange, and PIPE Offering • SNWV • Oct 18, 2024 9:31 AM
Vocodia Addresses Recent Stock Price Movement and Future Strategic Partnerships • VHAI • Oct 18, 2024 9:00 AM
Mass Megawatts Announces the Start of an Online Discount Solar Energy Equipment Business with Revenue Recognized for the First Time Since Year 2010 in this Fiscal Quarter • MMMW • Oct 18, 2024 7:32 AM
Unitronix Corp Advances DeFi Innovation with Tokenized Real-World Assets Integration • UTRX • Oct 17, 2024 7:38 AM