Weed Week: All eyes on the TGA after key decision pushed back to December
Health & Biotech
Health & Biotech
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November 25 has been and gone, and the TGA ruling on pharmacy distribution for low-dose CBD is… still forthcoming.
The federal health regulator said it now expects to hand down a decision some time in December, although it didn’t announce a specific date.
A key talking point prior to the announcement was dosage levels. The TGA was set to approve capped dosing levels per packet of 1,800mg — equivalent to 60mg/day over 30 days.
However, there’s currently no clinical research which proves the efficacy of CBD products at those levels.
In the wake of the announcement, Stockhead caught up with Clare Barker, managing director of medicinal cannabis company Entoura, to try and get some context around the delay.
Barker said health regulators actually dropped a clue early last week, in a virtual industry conference with presentations from John Skerrit (head of the TGA) and senior reps from the Office of Drug Control.
“In both of those sessions they mentioned the S3 (down-scheduling) decision and said the terms ‘mid-December’ and ‘late-December’,” Barker said.
“So a few of us in attendance pricked our ears up. We had some people reach out to lower-level TGA staff, and they said as far as they were aware the timing hadn’t changed.”
“So up until a week and half ago we thought it was a set date, but after that we realised it might not be.”
It’s possible evidence that TGA decision-makers are grappling the complex issue of dosing levels, following the first round of industry feedback to its interim decision in September.
“CBD products containing greater than 0.3 per cent THC were always going to be a difficult proposition for the TGA,” Leedman said.
“Investors should be focused on companies developing products with little to no THC that can demonstrate the clinical benefits of CBD without the mind-altering effects of THC.”
Barker added that TGA policymakers have also been processing industry feedback around CBD dosing levels since the interim decision was announced.
“A number of companies and industry groups raised the issue of the dose, and the fact there isn’t credible evidence around efficacy at that dosing level in published, randomised control trials,” Barker said.
It’s a relevant issue for a number of companies in terms of what the market will look like.
For example, Barker said two of the three CBD products Entoura manufactured would meet the 60mg/day criteria. But if the dosing level was raised, their third product would come into the mix.
In addition, lots of companies are waiting on the TGA to determine how they will allocate funding for clinical trials.
“Most companies don’t have patents on these products, so a lot of us are waiting on that dosing level to take the next step in our clinical trial programs. We have to make sure our trial work is actually what the regulator is looking for.”
And Barker added she “doesn’t envy” the TGA in their deliberations, because “I know they’re trying to get it right”.
“The last thing industry wants is to make CBD more accessible to patients, but then patients take it and it doesn’t work — that’s doing nothing for the industry so we really want to have it at the right dose.”
“But we also need to understand the difference between medication for long-term chronic pain — that’s where you want to get prescription (S4) treatment from doctors. The S3 schedule is meant to be for temporary relief-type conditions.”
To markets, and after outperforming in the week ended November 11, ASX cannabis stocks posted more strong returns over the past seven days.
Of the 36 cannabis (or cannabis-adjacent) stocks tracked by Stockhead, 25 posted a weekly gain, while seven traded flat and four lost ground.
Below is a summary of the latest weekly, monthly and annual price performance for ASX-listed cannabis stocks:
Scroll or swipe to reveal table. Click headings to sort.
Leading the pack was Cann Group (ASX:CAN), which ripped higher this week after getting a $50m loan from NAB which will go towards the construction of its medical cannabis production facility in Mildura.