Post by
subaru1i on Mar 05, 2024 10:28am
How do we know LABS, Pfizer, and we are waiting on DEA?
I posted the answer yesterday from the Q4, 2022 press release. Let me refresh everyone's memory per below again.
in 2022 MediPharm contributed active pharmaceutical ingredients to an Abbreviated New Drug Application filed with the United States Food and Drug Administration.
That was and is now a minimum of 14 months ago and FDA guidelines indicate ANDA reviews are completed in less than 1 year.
The FDA can review and complete their due diligence but CANNOT approve it when the approval encroaches on Federal law by way of existing DEA scheduling.
So theoretically, the FDA, based on clinical trial data and scientific evidence could have the ANDA approved but cannot release yet that approval.
ps: IT Virtu Group algorithm now working overtime, noticed that yesterday and today at the open because more real buyers are hitting the collared ask.
HAVE A GREAT DAY!!!