$AUPH Here is a look at majority of accelerated review approvals from 2019. I did remove a few that had initial CRLs or filing issues because I assume AUPH will not have issues. Key stats: 1) the top quartile of approvals (highlighted in green) received approval before PDUFA by average of -100 days 2) for top quartile Average approval time from Official NDA submission to FDA approval was average of 117 days People can debate this but bottom line is this will be the first ever drug for LN and there should be no reason FDA doesn’t act quick here.
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@auphlong @Medman42 @ResponsibleFox @nlrmandate @onemodolar @nomadragon I agree with all the above comments.....wild cards are IP dosing protocol on FDA approved label (I believe this is very close to 100% chance in our favour); strength of AUDREY results for dry eye in Q4/2020 (I expect they will be stellar). I expect NDA to be approved and AUDREY results released in October/November timeframe; BO announced by December for closing in H1/2021. This scenario should see a BO price well in excess of $50PS. Be assured that already, any and all big pharmas/biotechs globally will have been all over this with non-exclusive NDAs in place and so we should expect a bidding war launched very shortly after FDA approval. To the perfect strategic buyer this could go over $100PS IMHO. On the other hand, if we are not bought within the next 6-9 months then we’ll know that we didn’t receive a Board acceptable offer and will GIA. Indicators of that could be ex-USA license deals granted in 2020.