After reviewing your posts concerning the FDA 510k substantial equivalence and patents discussion. I decided it was time for me to familuarize myself with the process and do some "DD". Let me be the first to say that you are CORRECT concerning the 510k substantial equivalence, it is often used as a loophole. The MPDD was infact approved under the FDA 510k substantial equivalent of a TENS device. Where I DISAGREE with you and feel that insight for the board is much needed and currently the argument at hand, is that THIS IS NOT A BAD THING and still quite an accomplishment on behalf of SPOC and Dr. Norman Marcus. The FDA approval in terms of a 510k medical device just states that the FDA can certifiy that is AS SAFE as a TENS device because it was built on a simular platform. This has NOTHING to do with its purpose or anyones abilty to forecast its demand in the marketplace. It still takes hundreads of thousands of $$'s to engineer,test and file the necessary documents to achieve the 510k clearence even with the substantial equivalent and this CANNOT be understated. The theory that a medical device can be built in a garage and achieve this clearence is not true and very short sided unless you have TON's of money and are Albert Eienstein or Gutenberg. This is a common practice in terms of medical devices that companies such as Medtronic use in house. They develop devices built from a predicate device that has completely different functions but uses simular technology in order to capture the 510k approval,cuts costs and streamline production. Thousands of devices have been developed this way and have been very profitable for their companies. Of course their are devices that have been built with its predicessor in mind because technology in its self is evolutionary, its a constant progression of advancements. The MPDD has exposure and an actual use and EPGL has dont their part in asuring us that they have our best best interest and this is not opinon but displayed through their reaching of milestone such as thr DTC Chill. As far as the patents go....a patent is an the confirmation of an idea in a leagal setting..THAT SIMPLE. EPGL has no other way of legally binding their idea's other then using patents. Even if some other company has a simular idea expressed as a trade secret or patent, which I think is not the case as Dr.Marcus is a leader in his BIOMEM industry and beleive many of his future patents will be improvments to patents he already owns. The company can still use these as mean to improve their IP and gain value. Just as Samsung stole from Apple, and Apple and stole from Nokia. The PWC is a tired argument and honestly at the end of the day PWC has 3 seats on EPGL's board and has a fiduciary responsibilty in EPGL rather and behalf of AJW. PWC just like many of other companies that service acts on behalf of someone else, they're the reason why we are current, they're the reason why we had a R/S and they're the reason we're here today with such a great outlook. Their were over 100 companies in the NIR deal that went bad and we are only one still here because it was worht their time to restructure rather then liquidate. They're invested in equity and time.
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