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Biotech / Medical : Immunomedics (IMMU) - moderated
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To: patlawche11 who wrote (50141)2/8/2019 7:18:37 AM
From: Smoke Reader1 Recommendation

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patlawche11

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>I can't imagine where the status of 132 is right now, that the premium for selling the company sooner rather than later would get us past or even close to the highs of last August. They need to right the ship IMHO.<

In order to get the valuation back to the range we experienced during the months following the initial BLA filing, IMMUNOMEDICS would have to file the BLA re-submittal and re-start the FDA review clock...

Now, if I speculate with timelines and assume IMMUNOMEDICS takes 4 months to meet with the FDA + resolve any pending issues at the manufacturing facility + prepare the re-submittal pack, the refilling would take place sometime late in June 2019... I will also assume that the re-submittal is classified as CLASS II... Under this scenario, the FDA approval decision would come due sometime in December 2019... I look forward to management providing guidance regarding the timeline for re-submittal following the upcoming meeting with the FDA.

The entire scenario is starting to look like a replay of the initial BLA review process (but delayed by approximately 1 year)... I would venture that the PPS would follow a similar pattern as well starting from the date the re-filing actually takes place.
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