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exwannabe

10/20/22 2:27 PM

#523523 RE: skitahoe #523513

In short they've done all the things the regulators expect them to do, and they've provided guidance about what they're doing while waiting for the Journal to be published.


They have provided no guidance at all on the regulatory pathway going forward.

I have never heard of a dev stage bio failing to tell investors they are planning on submitting BLA/MAAs.

So, as they are keeping all informed, I guess they are not planning to submit.