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ghmm

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ghmm

Re: None

Monday, 06/03/2019 7:01:08 AM

Monday, June 03, 2019 7:01:08 AM

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Just to translate the (as usual) misleading PR the company gave. The PDUFA was almost certainly extended because additional materials were submitted during the review and FDA labeled them as a major amendment.

Don't think one can read too much into it beyond that as to a positive or negative outcome for the final decision.
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