Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-55

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arjay

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12/08/21

13:22

Post #: 55235024
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Originally posted by itsagas ↑

Antisense Therapeutics (ANP) – SPEC BUY – TP A$0.44 FDA feedback – delay to short-term catalyst but +ve FDA feedback provides further confidence of receipt upon submissionANP has announced this morning that it has received feedback from the FDA on its Fast Track Designation (FTD) request.
The response suggests ANP is required to finalise its complete response from an existing partial hold on its ATL-1102 drug and include its yet-to-be-completed 9-month toxicology study amongst the protocol synopsis which is expected to support the dosing of patients in the US beyond 6 months. Given FTD submission included updated trial design features in-line with feedback from the FDA Type-C and EMA which include higher and longer dosing regimens – it requires to button these last technical requirements up prior to re-lodging.What this means is that ANP will pull its FTD request and re-lodge once these tox studies are completed and a complete response accepted to ANP’s partial clinical hold on studies which are dosing >25mg/week. Overall, no impact to the timing of the trial commencement or completion although it does push out a pricing catalyst which investors would view favourably if received.Whether ANP received an FTD this month or a year from now after it generates the required studies doesn’t matter as FTD’s are used post clinical trial completion and are designed to facilitate and expedite the review of a new drug application.While this is a delay to a potential short-term catalyst, commentary from the FDA provides further comfort on the likelihood (assuming toxicology studies are +ve) of obtaining the designation: ‘DMD is certainly a serious condition, and it appears that ATL1102 may have the potential to demonstrate an effect on a serious aspect of the condition and provide benefit over currently approved therapies’.In a further silver lining, this advice is likely to push ANP to accelerate it’s complete response to the FDA partial hold. If accepted, ANP’s IND would become active and open (allows access to patients via clinical programs) as well as clearing the path for FTD consideration. View – net net neutral newsNo changes to our long-term view or forecasts. The delay of a short-term pricing catalysts is disappointing although offset by +ve commentary which is suggestive of FDA’s view on the applicability of the drug to treat DMD and likelihood that FTD to be issued once the technical details have been addressed.
We continue to be buyers in this name. Any weakness from short-term holders would present an opportunity to continue to add to holdings. Target price and recommendation retained.

From Morgan’s this Am....
Akki: Stop going on about Teva ...?who dropped Atl1102 picked up another drug which was a failure.. lol

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Where did you find this It'sa .nice article and makes complete sense...

Nice find..

ANP Price at posting: 18.0¢ Sentiment: Buy Disclosure: Held
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Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-55

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Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-55

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