Ann: US FDA Type C Meeting for ATL1102 in DMD, page-66

HI RYNZN

That is not a question you should be asking me, but i have previously answered anyway just take a look at our proposed PH2 through the EMA

Then go ask the company WHY

Please note i did not ask for the increased dose it was the companies preference to move forwards

Please note THE EMA key trial parameters is the inclusion of a 25mg dosing Arm, goes onto to say they ANP are now looking to include the 25mg dosing into the trial

30 July 2020 European Medicines Agency DMD Scientific Advice and Regulatory Process Update • EMA feedback reflects the prior scientific advice from the three EU national authorities on appropriateness of key trial design parameters • Inclusion of 25mg dosing arm into the study given demonstrated efficacy in Phase II • Company to define clinical and regulatory pathway in the US as a priority Antisense Therapeutics Limited [ASX:ANP | US OTC:ATHJY], (the Company) is pleased to advise that the European Medicines Agency (EMA) feedback reflects the prior scientific advice received from the three European Union national authorities on the appropriateness of the key trial design parameters of dose duration, safety monitoring plan, endpoints, and potential pivotal status for the planned Phase IIb study of ATL1102 in non-ambulant boys with Duchenne muscular dystrophy (DMD). In light of the positive Phase II trial results, the Company is now looking to include a 25mg dosing arm into the Phase IIb trial with the view that this could be a clinically effective dose in this study. The EMA advised that further rationale be provided for the selection of the proposed higher dose levels (up to 100mg per week) and for consideration to be given to the use of intermediate doses and an increase to the sample size (to around 35 patients per arm).

We all think this is fantastic, but what do you not understand that a controlled higher dosing could well improve results out off site

And if they don't then as i have previously stated we will be running the 25mg dosing along side

Do your research

Look and listen to what Pat had to say she was expecting Mg per Kg weight ratio

And yes i can understand Pats way of thinking

Go back to our 1103 studies and you will find that the company could basically define results and project outcomes not through Mg per wk but by Mg per Kg dosage

IE the bigger patients showed less effect than the smaller patients this was worked out from clinical results

This is what the trials are all about to control disease in patients without toxing them out and causing further problems

You make it sound like a ridiculous statement that we should include higher dosing, much the same as you did when you inferred it would be all over red rover with one meeting with the FDA, which is obviously not the case at hand

Anyway i am happy with my own research and from now on will keep my assumption's and and findings to myself sick of seeing the roses and rainbows some people on here need a reality check

GL with your investments

HULK dosing what a joke