Medipharm Labs Corp T.LABS

ANDA Sep. 2023

[Solid1]

The ANDA application was officially submitted to the FDA in September 2023: 

https://de.marketscreener.com/kurs/aktie/MEDIPHARM-LABS-CORP-62874327/news/MediPharm-Labs-Corp-gibt-Update-zum-Status-der-US-FDA-44484543/

That's exactly 10 months now and on average it takes 10 months. I expect news from Medipharm soon 

[alleyesonme]

https://stockhouse.com/news/press-releases/2023/08/01/medipharm-labs-makes-first-delivery-of-cannabis-clinical-trial-material-to-us

[QContinuum1]

The ANDA was confirmed (via Strachan on a recent CC) as being associated with Epidiolex.  If LABS has partnered with a pharma company that has NOT settled the lawsuit, then 10 months can become 100 months, it matters not. Given LABS has not spoken of the partner/lawsuit, one could conclude they are not partnerd with a settled party and thus have likely partnered with Apotex (which has not

[Solid1]

Simply change the name after approval 

[Solid1]

A generic only confirmed the same effect as the original! If it is approved for a completely new therapy, there will be no lawsuits against it. 

[alleyesonme]

What you speak of falls under the 505b2 application, an existing fda approved drug epidiolex(cannabidol a.k.a CBD) for a new indication, or dosage form..and thus, as I understand immune from existing patent protection....timing for this stock has frustratingly been a miss for all of us...2024...fingers crossed

[Solid1]

That's it ! The patents only apply to the approved therapy but not to the active ingredients 

[mdjbrown]

Solid, the September 2023 was a typo, and should have read September 2022.  Why the company did not issue a correction is beyond me, but the press release was made public on August 1, 2023 which of course is a month prior to September 2023. It was during the fall of 2022, that several Pharmacos filed ANDAs with the FDA related to Epidiolex as the initial exclusivity (NCE-1) date expired