PAR 6.67% 24.0¢ paradigm biopharmaceuticals limited..

Ann: Trading Halt, page-61

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  1. 1,216 Posts.
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    All analysis follows a statistical analysis plan or SAP, agreed prior to initiating clinical trials, so the biostatistician would've already known exactly what to expect and would've had ample time to prepare. The type of analyses required would differ in difficulty, but I assume whoever is performing the analyses is using software, so they just need to upload the data.

    The limiting factor or date of data release to PAR would've most likely been pre-determined by PAR, most likely to coincide with other price sensitive releases or corporate decisions, such as the issuance of the US patent on Tues/Weds.

    The key catalyst here I think will be the discussions with the FDA which should cause quite the frenzy. If PAR and FDA can agree on DMOAD requirements, then PAR could in theory apply for accelerated approval, particularly if they already have the data in hand. I'm unsure if PAR intend to wait for the canine results or if they will initiate discussions immediately.

    My views only, dyor.
 
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