Here’s the thing:
FDA is working with Anp to get the DMD drug to market ASAP.. but in order to get that Anp has to submit a paper re why it’s necessary and safe to increase the dose with a longer time frame...
Anp does not have to wait 90 days for a response..
Note : FDA did not reject Fast track .. Anp has to pull the application and re submit with details the FDA require..also note we got rare Paediatric and Orphan drug designation already...
Beware there are some on here who disguise their posts but have a hidden agenda...
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- Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD
Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-109
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