PAR paradigm biopharmaceuticals limited..

PAR. SP, page-1252

  1. 302 Posts.
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    There seems to be a lot of confusion about what the recent process with the FDA was. My understanding is that the first announcement was never going to be a straight forward go-ahead. They engaged with the FDA to figure out exactly what they wanted in the phase 3 IND application. They told PAR what they want, and PAR can now go ahead and submit for formal approval.

    PAR have done a bad job at communicating that, because clearly many were expecting a green light straight away, but that was never possible in the first place. My understanding could be wrong though.

    IMO only.
 
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