PER (ASX) Ann: US FDA Type C Meeting for ATL1102 in DMD

Originally posted by samfiodiving: ↑

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

Expand

Good point. Weight. Would be interested to know the weight of the kids where all had 25ml with efficacy. But 4 times heavier feels like a stretch. Thats some heavy kids. But yes, we have a drug that works well and approved for trial. thats what Ive been needing to reassert as your narrative is contradicting, sometimes.

No.	Vol.	Price($)
2	43377	8.0¢

No.

Vol.

Price($)

43377

8.0¢

Price($)	Vol.	No.
8.2¢	97561	1

Price($)

Vol.

No.

8.2¢

97561

No.	Vol.	Price($)
2	43377	0.080
2	212658	0.078
1	200000	0.077
3	91500	0.076
4	206988	0.075

No.

Vol.

Price($)

43377

0.080

212658

0.078

200000

0.077

91500

0.076

206988

0.075

Price($)	Vol.	No.
0.082	97561	1
0.083	214000	1
0.084	67142	2
0.085	141000	2
0.086	106100	2

Price($)

Vol.

No.

0.082

97561

0.083

214000

0.084

67142

0.085

141000

0.086

106100

(20min delay)
Last 8.0¢		Change -0.001(1.23%)		Mkt cap ! $72.12M

Open	High	Low	Value	Volume
8.2¢	8.2¢	8.0¢	$63.52K	777.8K

Ann: US FDA Type C Meeting for ATL1102 in DMD, page-67

SKS Technologies wins US$90M award to supply power to international hyperscale data centre in Melbourne

Almonty locks in govt agreement for tungsten oxide plant in South Korea

Infini soars 50% as company reveals it could’ve just made uranium history – redefining what it means to be “high grade”

BHP dips as WA nickel suspended after A$6B hit; losses eased by US CPI and forewarning

Nanocap Middle Island Resources kicks off Barkly copper-gold drill run – a potential IOCG-style NT project

ASX hits all time high out the gate on Friday trades following bullish US inflation data

Immutep reports strong response rate from immunotherapies treating carcinomas

Bitcoin investors need to know the risks

Week 27 Wrap: ASX hits all time high; CBA shares' two realities; US inflation hits 3% ahead of China plenum

Nimy to raise $1.21M to explore 'newsy' WA targets

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Ann: US FDA Type C Meeting for ATL1102 in DMD, page-67

Top Stories

SKS Technologies wins US$90M award to supply power to international hyperscale data centre in Melbourne

Almonty locks in govt agreement for tungsten oxide plant in South Korea

Infini soars 50% as company reveals it could’ve just made uranium history – redefining what it means to be “high grade”

BHP dips as WA nickel suspended after A$6B hit; losses eased by US CPI and forewarning

Nanocap Middle Island Resources kicks off Barkly copper-gold drill run – a potential IOCG-style NT project

ASX hits all time high out the gate on Friday trades following bullish US inflation data

Immutep reports strong response rate from immunotherapies treating carcinomas

Bitcoin investors need to know the risks

Week 27 Wrap: ASX hits all time high; CBA shares' two realities; US inflation hits 3% ahead of China plenum

Nimy to raise $1.21M to explore 'newsy' WA targets

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News