Applying for Emergency Use Authorization at US, UK
Post# of 153886
(Total Views: 771)
Posted On: 08/15/2020 2:15:34 PM
Applying for Emergency Use Authorization at US, UK, EU, Israel and Mexico really is a nice chess move by the company.
This places serious pressure on each regulatory body to decide if they want to pass on a drug with proven efficacy and unusual safety profile. Especially the FDA if it is found out that Mexico or the UK approve leronlimab and scoop up all available product and the FDA has been slow playing this company for years.
This is an easy sell to the UK as safety is established and NEWS2 was developed by their physicians. They are familiar with the scoring report.
Mexico may also be likely in that they were (according to NP) willing to approve on a small 25 patient trial.
So you get one taker and the FDA now has serious pressure to approve. No more P3 trial BS and long regulatory approval with endless hoops/hurdles to overcome.
This places serious pressure on each regulatory body to decide if they want to pass on a drug with proven efficacy and unusual safety profile. Especially the FDA if it is found out that Mexico or the UK approve leronlimab and scoop up all available product and the FDA has been slow playing this company for years.
This is an easy sell to the UK as safety is established and NEWS2 was developed by their physicians. They are familiar with the scoring report.
Mexico may also be likely in that they were (according to NP) willing to approve on a small 25 patient trial.
So you get one taker and the FDA now has serious pressure to approve. No more P3 trial BS and long regulatory approval with endless hoops/hurdles to overcome.
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