further to
@Exalted 's post
the process IHL are pursuing through the FDA / benchmark candidature for their drug designations will exceed TGA S3 low dose requirements.
Why?
CBD sits at schedule 4 ( must be
prescribed by 2 practicing physicians)
CBDVA, CBDV sit at schedule 8
You can access CBD product (150mg) via SAS which is at the
sole discretion of the physician only
TGA S3 introduction for CBD allows low dose (150mg max daily) behind the counter by a pharmacist.sounds great doesn't it?
However,
the product has a very high barrier to entry which very
few punters have their head around....the S3 medication means no physician required in the process at all - yet the barrier set for entry to this space is high
and there are currently
no products that meet this barrierwhat is the barrier?
Quality, safety and efficacy.....as per TGA guidelines for S3
Quality...
must be a GMP product thats' gone through the same cmc, same module 3
as any other pharmaceutical grade product( is there a botanical grade product today that meets those quality control requirements in Australia.....nope! TGA have not seen any as yet...doesn't sound at all 'recreational' )
= minimal batch to batch variation - can be scaled up accordingly and quality control maintained...etc
Safetymust carry and run a safety profile so the TGA can deem it 'safe product' up to a combined daily dose of 150mg
Efficacyyou must run and hold a
'label claim' on the product.....
can you think of a CBD product that makes and holds such a label claim at the moment - that has been verified by any regulatory authority, TGA or otherwise in the CBD medications?
there is only one as indicated by
@Exalted (and many other other contributing posters/holders here )and its GWPharma.....1 company globally...for Epidiolex, it has orphan registration with the FDA and was trialed by and funded by GW....USD $20 mill to bring to market ...their money.
So its clear to follow these parameter's to simply get a S3 up....phew! why?....too hard = nuts....
do the work and spend the money and arrive with something that will address the unmet clinical need globally across multiple treatment indications, that's a far more lucrative pursuit and greater risk / reward = $$$$$
that's the reason this company is a standout from the rabble here on the ASX - not very well understood by investors in Aus.
Many still confuse the recreational cannabis opportunity with the clinical/medicinal cannabis opportunity and think S3 is an easy ticket to the chocolate factory....nope....as can be seen from the above.
That's also the reason NO currently available S3 product in Australia......no brainer hey!
looking forward to the news flow
Good luck all
