i think that's right. the truth is nuanced. some
Post# of 154804
(Total Views: 344)
Posted On: 04/28/2021 10:59:51 AM
Re: Evil Rabbit #88239
i think that's right. the truth is nuanced. some self-inflicted wounds due to in experience for sure. and the FDA putting us through hoops - and not looking hard at the S/C data and saying "ok, this clearly works and it won't hurt anyone - let's accelerate via EUA".
but my view remains that the unknown company (new kid on the block) has to prove themselves beyond a shadow of a doubt - and our trials have left just enough of a shadow, they we're still sitting with no approval. and with vaccines getting momentum (thank god) therapeutics are on the back burner.
it's a bummer - and i worry that 2021 won't see an approval by the US FDA for us - at least at the current pace (we're almost to May). and i also worry that other countries, while liking our drug, will be slow to approve if there is no approval in our home country.
i hope i'm wrong and we get some huge news on an approval in Phillipines and other places and sell 2 million vials in 2021 - nothing would make me happier.
still super bullish long-term to be very clear.
but my view remains that the unknown company (new kid on the block) has to prove themselves beyond a shadow of a doubt - and our trials have left just enough of a shadow, they we're still sitting with no approval. and with vaccines getting momentum (thank god) therapeutics are on the back burner.
it's a bummer - and i worry that 2021 won't see an approval by the US FDA for us - at least at the current pace (we're almost to May). and i also worry that other countries, while liking our drug, will be slow to approve if there is no approval in our home country.
i hope i'm wrong and we get some huge news on an approval in Phillipines and other places and sell 2 million vials in 2021 - nothing would make me happier.
still super bullish long-term to be very clear.
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