RE:RE:RE:RE:Investor attitude toward managementalleyesonme wrote: LOL!!!! Read the CC transcript...read the MD&A...!!!!!! They 100% have a client partner who has "submitted" a NEW DRUG application..your motives are questionable, this is undeniable! Let me geuss? The earth is flat also?...back on ignore...
Ah yes, the CC and MD&A....here is a lesson in interpreting things differently (again). You read the investor deck and the MD&A, see the letters NDA and immediately conclude that they have partners that have submitted that NDA.
Indeed, page 9 of the most recent MD&A states: "MediPharm has international pharmaceutical partners who have referenced the DMF and finished goods in either a drug product filing or FDA investigational NDA."
Great you say, see, it's clear. But is it? The very next sentence states: "If any of our pharmaceutical partners are successful in their United States (“U.S.”) filings, any resulting drugs containing cannabis would gain marketing authorization (through an NDA or ANDA)."
Huh? The second sentence seems to mean that they need to apply for authorization via a NDA but the first sentence seems to mean they already did? What the heck does that mean??
Well, do you know what an investigational new drug application is? Here's a snippet: "An IND is short for “
Investigational New Drug” and is an application sent to the FDA for an exemption to lawfully transport and distribute an investigational new drug (a drug that has not been approved for sale) across state lines to conduct clinical trials and to administer it to humans. In other words, an IND is required when a sponsor intends to initiate a clinical trial or clinical investigation in humans"
So you see, the one word 'investigational' in the MD&A can throw your entire hypothesis into question. Bet you didn't know that. Certainly you will argue that LABS didn't call that effort an IND and rather an investigational NDA, but are you certain what they mean? If you say yes, either you're blind or naive.
So I say again, if you're so interested in the status of these various efforts, then I would send the investor relations person a message and ask. It is a fact that an ANDA has been submitted. Anything else at this point is a guess and opinion. Obviously many a person would love to know what you end up finding out.