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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?


To: Dietman who wrote (50177)2/8/2019 2:47:22 PM
From: bobbseytwins200114 Recommendations

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  Read Replies (3) | Respond to of 63276
 
We have heard all the discussions, ranting, and analyst updates and we have learned virtually nothing new. IMMU says they know the issues in the CRL amplified by the EIR and think they have taken care of what was mentioned. The FDA says the plant needs to be reinspected, but does not explain why it was not done before the PDUFA date, and/or why they apparently did not share the non inspection situation with IMMU. Regardless, it does not seem at all reasonable to us that it takes two months, six months or longer for the FDA to reinspect a plant that is producing a breakthrough product for a disease where the victims have no options. In addition the company says they are interacting with said FDA almost daily. What are we missing?