Post by
QContinuum1 on Jul 02, 2024 1:29pm
NDA/ANDA/505
These three processes are different and I would advise anyone looking at the LABS investor deck or listening in on calls to go to the FDA website and take a look.
I've discussed before that simply because the investor deck refers to these paths (and that LABS has 'partners' in all of them) does not mean that the 'partner' has submitted an application or has done anything formal at all. The only thing we have factual confirmation of is that the ANDA process (via the mystery Epiodiolex partner) has been entered into and that the legal proceedings are the decided factor there.
The NDA and 505 paths have never been openingly discussed at all and the MD&A makes no mention of them. We also haven't heard anything about these two paths (officially) so have no idea where, if at all, LABS/Partner are within the process(es).
We are in desperate need of an investor deck clean-up and also in need of on the record words about all of these things that cause some to enter into a frenzy (eg. over 20 late stage trials....ummmm no).
Hopefully the Q2 call with either have some material things to talk about, or some of the paid 'analyst' shills grow a set and ask LABS about the above.
Comment by
Solid1 on Jul 02, 2024 1:57pm
The ANDA and NDA filing was first mentioned in the Q3 2022 conference call. But then came the Jazz lawsuit, which presumably delayed everything, and finally the application was officially filed in September 2023. I assume the patent infringement was reviewed in the time in between
Comment by
QContinuum1 on Jul 02, 2024 3:04pm
ANDA is Epiodiolex, we know that. NDA is not and has not been mentioned.
Comment by
Solid1 on Jul 02, 2024 3:32pm
The ANDA will be approved for a new therapy, and the NDA has already been mentioned several times, most recently in the last quarterly report
Comment by
Solid1 on Jul 02, 2024 3:41pm
Not to forget the current study by Dr. Yasmin Hurd with a direct link to Medipharm - the results are also expected this year https://clinicaltrials.gov/study/NCT06206291?cond=Opiate%20Dependence&term=Yasmin%20Hurd%20&rank=4
Comment by
Solid1 on Jul 02, 2024 3:42pm
https://www.globenewswire.com/news-release/2019/05/22/1840842/0/en/New-York-City-Ichan-School-of-Medicine-at-Mount-Sinai-and-Renowned-Global-Researcher-Dr-Hurd-Select-MediPharm-Labs-to-Support-500-Patient-Major-Clinical-Study-and-CBD-International.html
Comment by
QContinuum1 on Jul 02, 2024 3:49pm
You mean the currently active Phase II trial? This is no where near ready for prime time.
Comment by
QContinuum1 on Jul 02, 2024 3:45pm
The acronym NDA certainly is mentioned in the last quarterly report, however as I've stated before as well, there is a big difference between a NDA and an 'investigational' NDA. The report refers to the latter.
Comment by
Solid1 on Jul 02, 2024 3:51pm
What exactly can you find at ....? Medipharm supplies the APIs or gets exclusive production and distribution licenses who knows... I know you'll just keep spamming