PAR has also had problems this year with getting its IND approved, despite prior meetings with the FDA to iron out any problems.
This was the comment by the PAR CMO at the time of its IND submission.
This IND submission is the product of several informative meetings with the US FDA and EMA where Paradigm’s clinical and regulatory teams received critical feedback on the requirements of the data package for submission and overall clinical trial design to ensure it would meet the regulators needs for registration. This led to adjustments in the OA clinical program to make sure Paradigm would have all necessary data to not only open the IND but also to have a harmonised global clinical trial design.
https://hotcopper.com.au/threads/an...-for-pivotal-oa-program.5978261/#.YVaEt5oRWUk
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