fair question - if safety data is good (and not sure i have ever...

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09/12/21

21:10

Post #: 58198939
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Originally posted by Goneallin: ↑

In their recent presentation, on slide 10, under the heading S3 registration, the company states the following:

Bod will become one of the first companies to introduce a Schedule 3 (Pharmacist Only) CBD product in AustraliaFollows recent TGA decision allowing low dose CBD products to be sold over-the-counter by a pharmacist to consumers without a prescriptionUnlocks a market valued at an estimated $250m - unregulated market valued at ~$3.5Bn highlighting potential product demandBod has entered into an agreement with Australia’s leading research group the Woolcock Institute as the lead investigator of the trialCollaboration allows Bod to progress a phase IIb clinical trial to test the efficacy of its unique CBD Product on symptoms associated with sleeplessnessPatient recruitment expected to start in January 2022with the 12 week trial expected to commence February 2022Following completion of the trial and receipt of an ARTG registration through the TGA, Bod will commercialise the product(s) in collaboration with multiple partners.

can someone please clarify exactly what stage BOD is up to with registering a S3 product? My interpreting of what they have written here, is after the phase 2b trial they will be going ahead with registering their product for over the counter sales, which all things being equal they may be in a position to do by the end of CY22. It is my understanding that they will need to do an additional stage 3 trial which blows this timeframe out by at least a year. This has huge implications from an investing perspective! Considering the lack of engagement I got with my last question I will add this statement: If you folk (who are invested in BOD) can’t answer this question, then you aren’t worth the money you have invested, just blindly swinging in the hope you get lucky. Surely one of you have an answer to such an important and basic question?

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fair question - if safety data is good (and not sure i have ever read df material risks or adverse effects from refined cbd) then my assumption is that if health claim is fairly lame like sleep benefit then s3 can be granted without p3 trials.

i think if their claim was curing cancer etc they would need p3 trials

but that is not the case

remember the only other TGa; FDA or NHS UK CBD drug was epidiolex for seizures and it did 500m of sales

risk return looks ok 2 me -giddyup

BOD Price at posting: 25.0¢ Sentiment: Buy Disclosure: Held
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0 Great analysis

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