It appears to me AGN intends to apply for an EUA due to success with 'time to intubation and coming off intubation" Secondary Endpoints. Of course there are 'Ifs" right now.
Also they cant discuss their progress about possible partnerships or of any plan for an additional PP which we all hope will be minimal.
Sure many/all of us wanted knock down interim data but I have not seen this from Any Pharma, big or small like AGN. NO 'cures' or treatments that truly outpace SOC that I see.
The continued statements about treating patient's ventilator needs seems a huge positive. Being included as part of treatment 'cocktails' has always been the Goal for Ifenprodil.
I feel the CEO will be making the 'rounds' showing the 'trends' seen and is trying to jam a foot in some doors.
A 2021 plan will include additional efforts to bring other repurposed Drugs forward. Of course.
"If the data is positive, the Company will consult with the U.S. FDA on an Emergency Use Authorization (EUA)."
The Company will also evaluate all aspects of conducting a Phase 3 trial, which will be required regardless of whether or not the Company receives an EUA.
The Company advises that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 (or the SARS-2 Coronavirus) "AT THIS TIME". "AT THIS TIME"
The longer than expected Data processing may indicate very thourough reviews of the Secondary Endpoint targets including 28 day + results...GLTA...
