Ann: MPL tablets arrive in Melbourne for MND Clinical Trial, page-35

Morning @Lastly

re: "It was certainly disappointing reading about these "minor impurities" in the first batch..."

Given the concern about these 'impurities', I think it's worth spelling out that this is an entirely normal occurance. Almost no drug is completely pure - even if it contains 99.999 percent pure API and intended ingredients (excipients, preservatives, polish for the coating, etc.) the drug sponsor or manufacturer will be required to characterise the 0.001 percent that is "impurities" when submitting their master drug file.

Impurities can occur in many different ways - for example, as a product of the manufacturing process or degradation of the drug over time while it sits on the shelf. The TGA expects this, which is why it is a requirement for these impurities to be properly characterised as part of the approval process. If anyone's interested, you can read more here:

https://www.tga.gov.au/sites/default/files/information_required_in_an_evaluient_in_listed_medicines_guidance_for_sponsors.pdf

https://www.tga.gov.au/sites/default/files/pm-argpm-guidance-11.pdf

It's mention in the release would seem benign to anyone familiar with the approval process but has clearly raised red flags for investors. Unfortunately, another case of poor messaging - while what was said is totally acurate, it seems that inadequate consideration was given to how the message would be interpreted by the casual reader (most investors).

Cheers

Densy