RE:_______ Facts _______Realstups, I forgot to mention the first BLA submitted Apr 5, 2017 is done as far as FDA; LMNL has to resubmit which starts the process from square one.
"
A refusal-to-file decision ends the review process.
The applicant’s options are to resubmit the NDA/BLA with the deficiencies addressed (the resubmission is considered an original new application) or to request that the NDA/BLA be filed over protest."
Management has chosen to resubmit the BLA with anticipated FDA approval in 2021.
Feb 2020 presentation. Click Here Page 11
realstocky wrote: FDA already reviewed riplazym, it was given a green light under conditional aditional checkpoints. Next review will take less than 6 months. Submission is confirmed h1 2020. Expect decision this year.
---------------------------------------------------------------------------
Knowing FDA will take at most 6 months for a decision and submission is h1, assuming the longest timeframes, what do you get? Now if u are thomvest and u play it conservative, do u say launch 2020 or 2021? Now realistically, do u think submission will happen last day of h1? do u think the FDA having already reviewed riplazym, will take 6 months? Underpromise, overdeliver... i would buy your shares ahead of the partnership for distribution that will happen iminently, when it happens u will buy them double or triple... or continue posting 10 posts a day on a stock u "hate".
From the corp. presentations couple weeks back:
Anticipated Key Milestones
1H-2020Expected commercial partnership for Ryplazim™
1H-2020Expected filing of amended BLA with FDA for Ryplazim™ (priority review expected)