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Re: Amatuer17 post# 107947

Wednesday, 08/19/2020 7:58:56 AM

Wednesday, August 19, 2020 7:58:56 AM

Post# of 233040
UK and EU operate independently of FDA. There are drugs available in Europe not currently available in the US. Every few years someone gets a bee in their bonnet about it:

https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2015/3/bill-wants-drugs-approved-in-europe-to-be-available-more-quickly-to-us-patients

So the idea the EU and UK wait on the FDA is absolutely wrong.

OWS- I haven't heard anything about it, it wasn't planned for so why even worry?

HIV BLA- 6 months or less. Nader may opt to just drop the self injecting device and just sell vials. People can buy their own syringes.

S2C- Fine with that.

EUA- Don't see how we are doomed, it just means P3 which we have to do anyways and HIV will be approved long before we run into any financial problems.

Everyone here seems to forget we were billed as an HIV and possibly cancer drug. This is just a curious detour.
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