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VikingInvest

10/04/22 5:29 PM

#519176 RE: flipper44 #519174

Spoke to one of the biotech analysts and he thought that because they are already approved for Specials, the manufacturing approval process should be faster than average as most companies do not have a specials program, so he is expecting news this month. That’s obviously just his personal opinion as they do not have coverage on OTC shares.
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no2koolaid

10/04/22 5:38 PM

#519179 RE: flipper44 #519174

flip, where some get confused is that the FDA approval process for new and generic drug applications includes a review of the manufacturer's compliance with the CGMPs. Based on what I have seen, MHRA has a risk based inspection subsequent to submission. Is that your understanding?
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j e d

10/04/22 5:48 PM

#519181 RE: flipper44 #519174

so what do you think the hang up is?
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sentiment_stocks

10/04/22 6:16 PM

#519185 RE: flipper44 #519174

Perfect... okay, thanks. That's how I understand the process to be as well.