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

To: MFG ENG who wrote (49549)	1/22/2019 11:23:18 AM
From: Planeteer	Respond to of 63308

I personally find these 5 findings to be very insightful and thoughtful. Having spent some time in consulting I find the arguments laid out #1 thru #5 compelling. The simple fact of the matter was that Venbio/Pehl et al were "blindsided" by the CRL. For one party to be blindsided in a two party interaction, it requires either one party being disingenuous or naive. The dissection of the 483 does clearly imply that re inspection would be a very fair assumption. How the FDA could make the company believe that approval was imminent with it's written responses to the findings seems disingenuous. If the FDA did not make those noises, or red flag it to the company it reinforces the feeling. If, on the other hand, the FDA made frequent reference to CMC concerns, and the company did not treat at a burning priority it is beyond naive. This is a well qualified mgmt team, but is there a lack of C suite experience. I've always had a niggle around how we could say the existing stockpile was fine when there were so many manufacturing issues of varying severity identified in August 2017. I am concerned as to the financial impact is the stockpile needs to be destroyed. What needs to happen in short order is a full autopsy between mgmt and FDA, it would be great to see resolution in 2019. The alternative is to sell to some real pro's. A week ago I wouldn't have dreamt of accepting an offer under $40 and would have sought $60 to $150. If an offer came in at $30 by this summer.... I would take it. We have a company that is ready to bring a drug to market, and is staffed accordingly, (with the associated headcount cost to bear) Apologies if this sounds like capitulation, but these poor women need this drug, and I have lost a lot of faith in the ability of this management team to deliver it.