Biovica – CEO video interview on the FDA Requirements

The main quotes from Biovica CEO Anders Rylander 5 minute interview with Redeye Research yesterday are below.

  • We got a very positive FDA feedback in February. That was very positive, because no more issues in the clinical area and only on study that we need to complement.
  • We will redo the study that we have done before. We are already working on it and the May deadline (for FDA response submission) we believe we should be able to meet.
  • We have performed the production of the samples and now we are doing the additional tests the FDA has requested.
  • This is not about new client test. It is about precision test we have done before – this is just in slightly different format with additional samples.
  • We are confident we can reproduce samples we have done in the past
  • We are confident we will meet the deadline
  • This should be the end of FDA review phase. After submission it generally takes 30-60 days for FDA to issue the clearance under normal conditions.

Full interview with Biovica CEO Anders Rylander below:

Follow up 7 minute interview with Warren Cresswell (President of the Americas, Biovica) with Redeye on lunching DivTum in the USA.

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