Not that my opinion means much(or anything for tha
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Not to berade our FDA but I don't think they are treating us different than any of the other 130 indications vying for COVID stardom. So I don't believe they are somehow giving us advice on how to get approval. They seem to send us snail mail letters, to communicate. Not exactly open dialogue. When some thought maybe the FDA wanted us to apply for btd because of our great anecdotal results in a couple cancer patients we got a big no...do it our way, you need preliminary meeting like everyone else.
Not that I want to be cynical, but seeing thoughts of people thinking the FDA is somehow guiding us towards quick approval, seems far fetched based on past history.
However I don't think we will be denied if the data is as good as cydy leadership thinks it is. It just might be a bumpier road than some think.
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