Below submission made by another entity. My key take-away is in that "THE COMPANY ASKED FOR PRIORITY REVIEW". So, JT did not indicate that AMRN would ask for PR from what I've read, just stating that it could take up to 10 months for approval of sNDA. Hmmmmm......so, is JT sandbagging some more in his mannerism of speak concerning label, etc. AMRN better damn well ask for PR, if that is how it is obtained. I don't expect the FDA to volunteer it out of goodness of their own hearts towards their good ol' buddies at AMRN!
Oops! Didn't see JL's post #170981 below before I posted this one. See that post for more in-depth. Mine would just be example of another entity's process and some of my dialoque, whereas his contains actual statute/FDA procedural processes.
On Dec. 21, 2018, AIMT submitted an application for a biological license for its AR101 immunotherapy treatment of peanut allergy in children aged 4 to 17. The company asked for priority review and will hear if it is granted within 60 days from the date of the application, which will be around the end of February. If granted, the company will hear from the FDA in six months if the application is approved.
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