Post by
subaru1i on Apr 18, 2024 2:34pm
A possibility, the ANDA and 505(b)2 could BOTH be CBD
based, could both or just one (generic epidiolex) utilize SEDDS technology and be applied as two different drugs in two different areas of health care. The logic for my thought is the single submission for CBD made by LABS to the FDA with regards to the DMF (drug master file).
IF they are both CBD or even if 1 of them is, the good news for LABS shareholders is that it is NOT dependent on DEA rescheduling cannabis from 1 to 3.
If we look at the logic LABS followed (CEO of LABS being former CEO of Purdue Pharma Canada), and that logic being doing a CBD DMF to the FDA along with ANDA and 505(b)2, imho, a strategy by the CEO of LABS that is not road blocked by the DEA what so ever.
I think those that give this some thought may see as the 'path of least resistance' and can only be thankful our CEO is from the pharmaceutical industry to lead us.