QRX 0.00% 2.8¢ qrxpharma ltd

Ann: QRxPharma Updates MOXDUO NDA Review , page-8

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  1. 1,057 Posts.
    I listened in and they pretty much reiterated what was in the announcement. We can expect up to a 3 month delay on the PDUFA date and the new AdCom meeting will be 4 to 8 weeks prior to that. This is yet to be confirmed by the FDA.

    Someone from the FDA was listening to the call though they didnt raise any questions obviously. There were a few questions targeting the FDAs take on this mistake but JH spoke of the 'cordial' relationship between them and the support they have received in accepting the new data and rescheduling meetings. There seems there's no impact to reputation here.

    Other than that the meeting was positive as they normally are.

    As at now the buy depth is at best thin. Lets see where this puts pushed today.
 
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