(Boursier.com) — Suits you partner of MedinCellprovides additional information about mdc-IRM’s application for approval.
Teva expects to re-submit the case to the FDA within the next 6 months, followed by a likely six-month review period
Kåre Schultz, Chairman and CEO of Teva, spoke today during the Q1 2022 results presentation. He provided insight following the recent receipt of a Complete Response Letter (CRL ) from the FDA regarding mdc-IRM’s application for approval.
He first clarified (excerpt from the results presentation): “We announced a few weeks ago that we had received a CRL regarding the long-acting injectable risperidone. We will therefore answer the questions we have received from the FDA. We expect this could result in a re-filing within 6 months, followed by a review period of probably 6 months. We still believe strongly in the concept and the efficacy of the product. We still believe we have approval, but there will be a delay of up to 12 months.”
He then added during the Q&A session: “[à propos de] the CRL, I can’t give you all the details, but I can say that it has nothing to do with efficacy and safety. We have very good efficacy data and very good safety data. We are very confident in the very principle of the product”.
“These are details of the conduct of the clinical trials that have been performed and certain items, which we are confident we can address, correct and report to the FDA within a maximum of 6 months. We then expect a 6 month review period. We are very confident that the product will be approved.”
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