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Biotech / Medical : Immunomedics (IMMU) - moderated

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From: Rivegauge1/19/2019 9:21:15 AM
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They received a 483, the meet with FDA after the official 483 is issued . They had been having meetings with the FDA since including face to face .

Typhcallh you get approval letter / rejection or conditional approval.

I am not sure why it appears most people want to blame the FDA when it’s apparent they had not done west been told

One should ask ,
- who is in charge of Mfg?
- since they had over a year to work on things ( this is a fact not a wild accusation) they became aware of this in 2017 by employees prior to Morris taking over everything
- who read the FDA meeting minutes?
- what was the plan they proposed to FDA and timeline associated?

Hopefully in couple of months the dust will settle and more I formation ( accurate on hopes not from Immu ) will surface to put this to rest .

This is based on facts and biotech/ fda experience
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