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Biotech / Medical : Immunomedics (IMMU) - moderated

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From: ladyPI	1/22/2019 4:52:57 PM
	23 Recommendations Recommended By bobbseytwins2001 captcobra1 CelebrityEquity chandler27 erickerickson and 18 more members Read Replies (3) of 63307

I got this portion of a Morgan Stanley report issued today from he who has been cast out and forever will wander alone in anonymous shame. Based upon this note and his references that are highlighted, the CRL was driven by a manufacturing issue or issues, which does not equate with a quality or impurity issue. Among the questions we both have is why can't the FDA come and test that batches that were ready to be shipped today? The FDA can also approve this drug with a PMC ("Post Marketing Commitment") and/or PMR ("Post Marketing Requirement(s)"), which should also be a proffer when a meeting is eventually arranged with the FDA. If the drug tests safe and there is plenty on hand (the company has been making it for a year), this would seem to be a sensible solution. Here's Morgan Stanley's take on things: What we know so far: (1) Mgt. indicated that there are less than a handful of open issues remaining. Mgt. indicated these issues are NOT related to the prior issues raised in the FDA 483 letter from the summer. However, mgt. would not provide specific details around the CRL beyond their belief that the issues are addressable; (2) Based on mgt. commentary we believe the issues relate to items mgt. believed were addressable post-approval while FDA has decided the issues need to be addressed pre-approval; (3) Mgt. indicated they are familiar with the issues and can start work at-risk pending a formal FDA meeting. Mgt. believes that a class 1 resubmission is possible (2 months versus 6 months review), but that decision is ultimately left up to the FDA; (4) Mgt. will seek an FDA meeting immediately and believes such a meeting could occur rapidly given BTD status. We await further guidance from mgt. on timelines to remediate the issues and formal FDA interaction; (5) Mgt. continues to believe it can use its existing supply chain for approval and transition to its partnership with Samsung BioLogics for commercial supply by 2020; (6) Mgt. highlighted that no additional clinical data was requested and that ongoing clinical studies will not be negatively impacted. That's all for now, but the Ronin is not dead, and fights on.... Compliments from you know who! He who wanders alone . . .

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