- Little Green Pharma (LGP) and its subsidiary welcome the Therapeutic Goods Administration’s (TGA) decision to allow psychiatrists to prescribe psilocybin and MDMA to patients
- The TGA’s decision paves the way for Australia to become the first market in the world to recognise psychedelics as medicine to treat depression and PTSD outside of a clinical trial environment
- LGP’s subsidiary, Reset Mind Sciences, is now positioned to cultivate and supply psilocybin for its impending clinical trial, while also nearing the end of construction to its bespoke mushroom cultivation facility
- Meanwhile, Little Green Pharma announced its intention to demerge Reset, with eligible LGP shareholders receiving a separate direct shareholding in Reset Mind Sciences, along with the opportunity to invest additional funds
- Little Green Pharma soars 37.8 per cent, trading at 25.5 cents at 2:43 pm AEDT
Little Green Pharma (LGP) and its subsidiary have welcomed the Therapeutic Good Administration’s (TGA) decision to allow psychiatrists to prescribe psilocybin and MDMA to patients.
The TGA handed down the decision on Friday, paving the way for Australia to become the first market in the world to recognise psychedelics as medicine to treat depression and PTSD outside of a clinical trial environment.
The TGA stressed the drugs have only been approved for use under controlled medical settings by authorised psychiatrists.
The decision has arrived earlier than expected by the industry, given the TGA’s verdict in December 2021 not to reclassify the psychedelics.
The company’s subsidiary, Reset Mind Sciences, is now positioned to cultivate and supply psilocybin for its impending clinical trial.
“We have put more than 18 months of detailed planning into our trial with a focus on testing, refining and developing the therapy protocols that go along with the administration of psilocybin,” Reset Mind Sciences CEO Mr Shaun Duffy said.
“This is a specialised field of expertise in itself that should not be underestimated, and our trial provides an environment to optimise our protocols.”
“We have assembled an outstanding team of therapists that are trained and ready to go once we finalise the ethics approval process.”
These developments will also allow Reset Mind Sciences to accelerate and implement its commercialisation plans far earlier than expected.
Meanwhile, Reset is also in the final stages of commissioning construction of a bespoke mushroom cultivation facility, which is expected to be on site at LGP’s existing cannabis cultivation facility in the coming weeks.
Reset is one of a very limited number of Australian companies legally permitted to cultivate psilocybin containing mushrooms, with the aim of producing GMP grade psilocybin from its mushrooms as soon as possible.
“We’re still working through the full implications of the TGA’s decision for our strategy moving forward but suffice to say it’s a very positive development for us and will result in an acceleration of our plans.”
Throughout all this, Little Green Pharma announced its intention to demerge Reset by way of an in-specie distribution of its current ownership out to its shareholder base.
If approved by LGP shareholders, eligible LGP shareholders would receive a separate direct shareholding in Reset Mind Sciences, along with the opportunity to invest additional funds into it
“Given this regulatory development and that Reset is on the precipice of becoming operational on both the clinical trial and cultivation fronts, we believe the time is right to move ahead with the demerger of Reset Mind Sciences from Little Green Pharma into a standalone dedicated psychedelics company,” Mr Duffy said.
Little Green Pharma have rocketed up 37.8 per cent, trading at 25.5 cents at 2:42 pm AEDT.