510K response from FDA on GenChoice The rumor
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Posted On: 02/07/2019 11:50:27 AM
Re: nonsequetor #6464
510K response from FDA on GenChoice
The rumor is...
They received their first written response from the FDA Wednesday. The application appears to be on fast track . The FDA waited 29 of the 30 days to accept the 510K application, which should be expected, but the FDA did not wait 29 days to ask for a 60 day extension, which is also common. Shareholders and interested parties will not be able to see these communications ...Mr. Berman will [not] share any of the information received in phone calls from shareholders, due to the fact that the process is hidden from the public (for reason of trade secret protection), except in instances where the company divulges information, where then the owner of the predicate device can subpoena all correspondence. KB will attempt to pick the time and place to battle the predicate device big pharma.
The rumor is...
They received their first written response from the FDA Wednesday. The application appears to be on fast track . The FDA waited 29 of the 30 days to accept the 510K application, which should be expected, but the FDA did not wait 29 days to ask for a 60 day extension, which is also common. Shareholders and interested parties will not be able to see these communications ...Mr. Berman will [not] share any of the information received in phone calls from shareholders, due to the fact that the process is hidden from the public (for reason of trade secret protection), except in instances where the company divulges information, where then the owner of the predicate device can subpoena all correspondence. KB will attempt to pick the time and place to battle the predicate device big pharma.
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