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Biotech / Medical : Immunomedics (IMMU) - moderated
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From: stockdoc772/7/2019 11:04:16 PM
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This turn of events makes it even more clear that management was profoundly delusional. They were planning a party instead of realizing that they had no chance of getting AA given that the 483 issues were not resolved to FDA satisfaction, even though they claimed they thought they were. Favus had a lot wrong, but they were right to highlight the 483. This is where I cannot give Behzad et al a pass. When you are this deluded it is on you, you cannot blame the FDA or the horoscope. Morgan Stanley is the only analyst I know of that is still holding out hope for a Class 1. A reinspection is by definition a Class 2. They have not even asked for a meeting with the FDA. I will be profoundly surprised if they refile the BLA before July 1. The last thing they want to risk is rushing the job and screwing it up again.
If anyone had said in December 2016 that Behzad would not get AA till 2020, they would have been booed off the board. Well, that's likely what's going to happen, and that's only if they don't screw it up again, which remains possible, and that the P3 trial doesn't report a negative result, which destroys the company. I'm not sure they have control over that, but slowing down that P3 would likely be the best business decision they could make.
Hoping that the FDA does not use all its allotted time is a pretty thin reed.
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