Medipharm Labs Corp T.LABS

Lots of good gouge in this article.

[Lvlchange]

https://stratcann.com/financials/medipharm-labs-reports-continued-growth-in-canadian-international-markets/

This answers many questions include a mention of the US FDA.  Still a garbage stock but with many hopes and dreams.

[rejaj]

Lvlchange, thank you for the link. Excellent fact based article that provides some background insight into recent events. More of this would be welcome. And yes I agree, it is a "garbage" stock if looking for a quick winfall. But in all truthfulness, if one were to step back and look at the direction the company is going, they are doing all the right things. It takes time to grow a

[QContinuum1]

Older review and doesn't really say anything that isn't already publicly available via the LABS investor deck, MD&As or even in the Danny Deadlock analysis paper. I do like that they distinguished that the NDA is actually an investigational NDA mind you since it appears there is still confusion as to what the 'NDA' submissions actually mean.  The ANDA is Epiodiolex and

[subaru1]

Well said Qcontinuum1, we need somthing major to happen or at least a growth of 20 to 30% qrt after qrt for the next year or two. i am very patient always expecting that something good will happen, we are still sitting at $0,07 while management are overpaid based upon the results. They say that we should be at $0,15 we are half that price because of them so they should cut their paid by half at

[okgonow]

if things have not turned arround in tearms of SP by the time the next AGM vote on management and stock options is. I will be a firm NO vote on both!!!!!!!!!!!!!!!!!!!! Pidduck and crew has had enough time now to get this company turned arround with the catalysts especially Germany(europe) and SP has not moved towards the $.15 which is still rediculosly low.  thats all I have to say

[Solid1]

USC (University of Southern California) Keck School of Medicine Treatment of Alzheimer's agitation disorder Phase 2 approval by the FDA for an investigational new drug (IND) Clinical trial material (‘CTM’) delivered, and recruitment began in the 3rd quarter of 2023 The second CTM delivery took place in the 4th quarter of 2023. This is an IND and has nothing to do with

[QContinuum1]

Keck is phase 2 and may as well be eons away in terms of completion.  It won't do LABS any good for a long while. If the Keck trial is indeed the investigational NDA referenced, there is no other NDA in flight apart from the ANDA and we know what that's all about.

[Solid1]

That is not the point. The NDA/ ANDA filings that Pidduck spoke about in a conference call are completely different regulatory filings from a pharma partner for whom Medipharm supplies the active ingredients, presumably a 505(b)(2) approval that consists in part of an ANDA and an NDA 

[QContinuum1]

Repeat after me, there is no NDA apart from the investigational NDA. 

[Solid1]

The ANDA filing can only be a 505(b)(2) filing, which is the equivalent of an NDA. That's how it's presented in the investor presentation. And Pidduck talked about the application and referred to it as an NDA. The active ingredients of Epidiolex cannot be patented. So if a new therapy is discovered, Epidiolex can be marketed as a new drug without infringing the patents. The new drug may

[QContinuum1]

ANDA = Epidiolex Investigational NDA apparently = Keck trial That is all.

[Solid1]

There is also a Pre IND for a 505 (b)(2) application that you submit to the FDA first. And yes, the ANDA application is for Epidiolex, but as a new indication and for guidance for the drug Epidiolex, which is already approved. The active ingredient CBD is the same in both. Just don't give up 

[Solid1]

I also think it's beneficial for Medipharm Labs to keep cannabis on Schedule 1 in the US, because if their generic of Epidiolex is approved, it would automatically be on Schedule 5, just like Epidiolex itself. This means that the other manufacturers of CBD would not be medically recognised and the US market would remain closed to them. 

[subaru1]

It seems anyway that this Reschedule has no end, it has been almost 3 years now that it is in process and other than having discussions and more discussion and waiting after this and that the schedule form 1 to 3 is still not done and if it is not done before november it will probably take years before it happens. They will wait and wait after all kind of studies, by the way the youngster at the

[Hunter34]

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