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Bullboard - Stock Discussion Forum Medipharm Labs Corp T.LABS

Alternate Symbol(s):  MEDIF

MediPharm Labs Corp. is a Canada-based full-service pharmaceutical company. The Company specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products. Through its wholesale and white label platforms, the Company formulates, develops (including through sensory testing), processes,... see more

Bullboard (TSX:LABS)

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Post by Solid1on Sep 02, 2024 5:45am

ANDA - 505(b)(2)

The most important point for me was that Jazz/GW Pharma's exclusive rights to New Chemical Entities (NCEs) expired in September 2023, just as Labs' pharma partner was filing its ANDA. 
Comment by Hunter34on Aug 30, 2024 4:12pm

RE:Rescheduling could be Positive turn of Events :) $$$

USA will never give up on their Criminal War On Drugs and Humanity...end them...
Post by 1hot-techwomanon Aug 29, 2024 8:21pm

Rescheduling could be Positive turn of Events :) $$$

https://www.youtube.com/watch?v=zha2WEJSKoE
Comment by subaru1on Aug 29, 2024 10:52am

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Lots of good gouge in this article.

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 ...more  
Comment by Solid1on Aug 29, 2024 5:20am

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Lots of good gouge in this article.

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 ...more  
Comment by Solid1on Aug 27, 2024 4:24pm

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Lots of good gouge in this article.

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 ...more  
Comment by QContinuum1on Aug 27, 2024 3:42pm

RE:RE:RE:RE:RE:RE:RE:RE:RE:Lots of good gouge in this article.

ANDA = Epidiolex Investigational NDA apparently = Keck trial That is all.
Comment by Solid1on Aug 27, 2024 2:13pm

RE:RE:RE:RE:RE:RE:RE:RE:Lots of good gouge in this article.

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 ...more  
Comment by QContinuum1on Aug 27, 2024 10:49am

RE:RE:RE:RE:RE:RE:RE:Lots of good gouge in this article.

Repeat after me, there is no NDA apart from the investigational NDA. 
Comment by Solid1on Aug 27, 2024 9:17am

RE:RE:RE:RE:RE:RE:Lots of good gouge in this article.

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 ...more  
Comment by QContinuum1on Aug 27, 2024 8:55am

RE:RE:RE:RE:RE:Lots of good gouge in this article.

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 ...more  
Comment by Solid1on Aug 27, 2024 4:39am

RE:RE:RE:RE:Lots of good gouge in this article.

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 ...more  
Comment by okgonowon Aug 26, 2024 2:49pm

RE:RE:RE:Lots of good gouge in this article.

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 ...more  
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