Here’s LGs verbatim: “but if we as part of our dialogue with them we heard there was something wrong (29:14) we'd have to say so and that would be material so no news is good news we're on a track for an accelerated approval (29:21) we're thinking sometime later in the fall we'll have something to say about that in the quue we file probably (29:28) tomorrow.
Talking about something in the fall is not saying approval will be that time. Since when has the Co. ever tipped their hand about timelines publicly? He did not hint at which RA/RAs either… I still go with MHRA by July 1 and FDA/Canada/Australia through new pathway by election time, which is also in the fall.
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