Per the fda - 4-22-20
“We are working on templates that could be used for home collection and home testing but they are not near ready yet to share.”
That is typical of the FDA. They are saying that they do not have the expertise or the quick thinking people in their EUA crew to deal with individual use Covid-19 kits, and cannot yet pick winners and losers. So, for now he would like to see every individual test kit as a loser until the bureaucracy can catch up in the next 12 months.
Well, that is too effing bad and it should not stop Berman. An agency saying they are not yet ready should NOT stop an applicant from being ready. If the applicant has a product ready and the product will do good, then the applicant has the right and the moral obligation to submit it. If Tim Stenzel isn't ready then he should be replaced. Stenzel came from business -- unfortunately Bay Area business. I am sure Trump does not know him, he was just a name on paper. Effing up this job of managing Covid-19 medical devices will seal his doom. Show of hands -- how many in the USA think the FDA is doing a good job with the Covid-19 test kits?
Stenzel is new at the FDA, well he's been there about 15 months, and he is a Trump appointee. But unfortunately he's one of the guys Scott Gottleib gave up and left the dysfunctional FDA over. New to the job, Stenzel decided his job future depended upon being lead by his nose by the Obama (and before) hangers-on. Too bad for him.
“We are working on templates that could be used for home collection and home testing but they are not near ready yet to share.”
That is typical of the FDA. They are saying that they do not have the expertise or the quick thinking people in their EUA crew to deal with individual use Covid-19 kits, and cannot yet pick winners and losers. So, for now he would like to see every individual test kit as a loser until the bureaucracy can catch up in the next 12 months.
Well, that is too effing bad and it should not stop Berman. An agency saying they are not yet ready should NOT stop an applicant from being ready. If the applicant has a product ready and the product will do good, then the applicant has the right and the moral obligation to submit it. If Tim Stenzel isn't ready then he should be replaced. Stenzel came from business -- unfortunately Bay Area business. I am sure Trump does not know him, he was just a name on paper. Effing up this job of managing Covid-19 medical devices will seal his doom. Show of hands -- how many in the USA think the FDA is doing a good job with the Covid-19 test kits?
Stenzel is new at the FDA, well he's been there about 15 months, and he is a Trump appointee. But unfortunately he's one of the guys Scott Gottleib gave up and left the dysfunctional FDA over. New to the job, Stenzel decided his job future depended upon being lead by his nose by the Obama (and before) hangers-on. Too bad for him.
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