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Re: StealthGold post# 183106

Friday, 09/10/2021 9:46:20 AM

Friday, September 10, 2021 9:46:20 AM

Post# of 233118
They have gone through an approval process for a device. That's a 510K.

A 510K document can run from 35 pages to 100 pages.

A BLA is 500,000 pages.

Those 2 13Ders have about 1 % of the needed experience to get the BLA approved.

That's like saying an RC car toymaker has the experience to be a car designer at Tesla.

The other difference between them and the current management is that current management are developing the drug , finding how it specifically works and they are building the BLA and getting "Actual" expertise in to vet the BLA.

Jmo
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