Obviously continue with the plan for FDA approval,
Post# of 11803
(Total Views: 578)
Posted On: 05/01/2020 10:17:31 AM
Re: BC Silence #10226
Obviously continue with the plan for FDA approval, but launch in other markets.
First comment: Yes!!!
Second comment: The Trump Administration recognizes this problem with the FDA, and will soon replace HHS Secretary Azar. The part of the job Azar did worst was management of the FDA, an agency run as if it were a political action committee for big pharma. The new HHS Secretary will have the task of cleaning up FDA, and doing it quickly.
But there are two other parts to this issue.
a. NIH was recently given $1.5 billion to pay bounties for new testing technologies. I would expect DECN to apply for the pries as soon as there is some sort of form to fill out.
b. Trump, who is furious with the FDA, who blew it with the ventilators and the test kits, in typical FDA fashion where they decided to choose winners and losers but again chose wrong. So Trump set up a quiet White House group, no big announcement, no fanfare, under the management of Dr. Birx and an Admiral who's name escapes me at the moment. This group is working hand in hand with the MDMA (Medical Device Management Association) and Birx and the Admiral have been given the authority to review and approve new technologies, in particular those technologies that identify the antigen Corona virus directly (GenViro! is one such product). The overall focus if the Birx group is to identify kits for business and at-home use. Sound familiar.
I expect DECN to file for EUA for their at-home use version of GenViro! in the next few days, perhaps today. So, the DECN application will be filed in Silver Springs, MD and then migrate electronically over to the White House.
A well deserved round of applause for Le Grande Orange.
First comment: Yes!!!
Second comment: The Trump Administration recognizes this problem with the FDA, and will soon replace HHS Secretary Azar. The part of the job Azar did worst was management of the FDA, an agency run as if it were a political action committee for big pharma. The new HHS Secretary will have the task of cleaning up FDA, and doing it quickly.
But there are two other parts to this issue.
a. NIH was recently given $1.5 billion to pay bounties for new testing technologies. I would expect DECN to apply for the pries as soon as there is some sort of form to fill out.
b. Trump, who is furious with the FDA, who blew it with the ventilators and the test kits, in typical FDA fashion where they decided to choose winners and losers but again chose wrong. So Trump set up a quiet White House group, no big announcement, no fanfare, under the management of Dr. Birx and an Admiral who's name escapes me at the moment. This group is working hand in hand with the MDMA (Medical Device Management Association) and Birx and the Admiral have been given the authority to review and approve new technologies, in particular those technologies that identify the antigen Corona virus directly (GenViro! is one such product). The overall focus if the Birx group is to identify kits for business and at-home use. Sound familiar.
I expect DECN to file for EUA for their at-home use version of GenViro! in the next few days, perhaps today. So, the DECN application will be filed in Silver Springs, MD and then migrate electronically over to the White House.
A well deserved round of applause for Le Grande Orange.
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