@PostmanPat - again that is rather simplisticIf you go to page 1...

@PostmanPat - again that is rather simplistic

If you go to page 1 of the CEO's report to the AGM you will see their list of approvals. Of additional interest is that you need regulatory approval to trial a drug- so technically all of their drugs in clinical trials have been "approved".

Also you should examine the risks associated with drugs in the key phases of biotech research to see that PXS has something well beyond nothing.




Discovery - Key risk is that you will have no drug/medication that is useful for anything.

Preclinical trial - Internal lab testing and R&D to measure toxicity, determine mode of action etc to ensure you won't likely kill people in clinical trials and you have something which will plausibly work.

--- At this point you have a company that can raise capital on something other than complete blue sky. Typically this capital will be used to continue R&D and fund clinical trials ---

Clinical Phase I - Small group of healthy test subjects to test side-effects and risks. Key risk is that the drug will not be safe to be administered.

Clinical Phase II - Medium sized test on eg healthy and unhealthy patients to see whether the drug works. Key risk is that the drug will not work (effacacy trials).

--- At this point you will have a very good understanding of a base line of value because most of the risk has been taken out of the equation. This also describes where PXS is for many of its drugs ---

Clinical Phase III - Large scale tests on a mix of healthy and unhealthy patients to confirm the results of Phases I and II.


--- TGA approval --- If Clinical Trial III is passed then it is a rubber stamp to start selling. it is legal to sell the drug. However in eg Australia there is a separate assessment - the cost / benefit equation. If the cost of the drug is too great then Medicare will not put it on the PBS which means it is effectively dead.

Clinical Phase IV - Post sale - to confirm ongoing effectiveness, explore off label applications, and otherwise look to extend patents.