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Msg  50280 of 50374  at  1/16/2020 5:21:29 PM  by


The following message was updated on 1/16/2020 5:24:28 PM.

 In response to msg 50279 by  Biotechbeagle
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Re: Enyedy punts

According to them they are trying to get an initial approval on both leading compounds ASAP.
For MS: SORAYA may end up being single PII but according to what management is saying about their conversation with the FDA, a stat-sig result in ORR with >= 6 months DOR would support registration by FDA guidance; they cited prior approval history on similar evidence in this indication as well. They did announce that they think they have sufficient cash to operate through topline data for SORAYA (which I expected.) No announcement of enrollment in MIRASOL.
For 632: they are banking on a fast approval in BPDCN with breakthrough designation for a post Elzonris population. No particularly revealing questions though.
I don't know that they will reveal a deal by Feb 14th; it very well may occur sometime later this year instead. I think they may just announce cash guidance for year end 2020 and through SORAYA readout on the 14th.

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