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

To: sukit who wrote (50222)2/8/2019 10:14:05 PM
From: weatherproof11 Recommendations

Recommended By

and 6 more members

  Respond to of 57069
Typical BLA review time = 10 months; Priority review = 6 months

Form 483's not uncommon, often followed up by future inspections and additional 483's all performed within the standard 10-month time frame

FDA backlog precludes them from performing post-483 re-inspection within the priority review 6-month time frame

Government shutdown exacerbates timing issues

FDA issues CRL to buy time

FDA will perform re-inspection any day now

What's built into the current price is a Class 2 resubmission with its 6-month review.

If the above scenario plays out, stock goes back to $20's

Next best case, FDA classifies resubmission as Class 1, stock goes to $18

Most likely scenario, Class 2 resubmission = Time for IMMU to fix problems plus 6-month FDA review, stock

hovers around present price of $14

Worst case, weatherproof runs out of present stock of Sambuca Romana and has to call it a night