The January 21 ann. said that:
"The Company wishes to advise that it has received confirmation from Quantum Pharmaceuticals Pty Ltd (Quantum) that production of the first batch of ThermaLIFE? Cream has been successfully completed and is currently undergoing a testing phase."
To me, this says that the testing phase has BEGUN. Please note that this testing COULD be accelerated shelf life testing. As an example, 6 months accelerated testing could be used as evidence for something like 18-24 months shelf life. If it began in January, it would be finished by June/July.
Thermalife is a Registered therapeutic good on the ARTG which means that it MUST show stability data before being released. This excerpt is taken from the ARGCM (Australian Regulatory Guidelines for Complementary Medicines):
"All applications to Register a complementary medicine must include stability data for the proposed finished product. The stability data must be sufficient to demonstrate, or indicate with a high probability, that the product intended for market will remain safe, of consistent quality and efficacious throughout the product?s shelf life. The stability data will form the basis for setting a shelf life and recommended storage conditions for the product."
The June 17 ann. says that the product has been Registered on the ARTG.
With regards to the production time line, it is important to realise that a lead time of 12-14 weeks is not out of the ordinary. So from June 17, when production was allowed to start based on TGA guidelines (after the product was Registered on the ARTG) 8 weeks have gone by. Still have faith that this is a good product.
Furthermore, distribution agreements are notoriously difficult to finalise, so it may take a little more time.
Hope I haven't bored everyone, but it's important to know the process and not panic.
Only in my opinion.
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The January 21 ann. said that:"The Company wishes to advise that...
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