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MedinCell’s partner Teva provides additional information regarding the New Drug Application for mdc-IRM

May 3, 2022

 > Teva expects a refiling within up to six months followed by probably a six-month review period 

Kåre Schultz, CEO of Teva, spoke today at the Q1 earnings call of Teva. He gave information following the Complete Respond Letter recently issued by the U.S. FDA about the New Drug Application (NDA) for mdc-IRM. 

He first said (extract from the earnings call): 

“We communicated some weeks ago that we received a CRL on risperidone LAI. So, we will be answering the questions that we got from FDA. We expect that this could cause a delay of a refiling with some up to six months and then probably a six-month review period. We still have strong belief in the concept and in the efficacy. So, we still believe to get this product approved, but there will likely be a delay of up to 12 months on it”

And he added during the Q&A session: 

“[about] the CRL, I can’t tell you all the details, but I can tell that it has nothing to do with the, you could say efficacy and safety. We have very, very good efficacy data, very good safety data. We are very confident that the principle works very, very well.” 

“But it’s to do with some details around how you could see the whole execution of the clinical trials have been done and some details there which we are confident that we can address and correct and communicate back to FDA within a maximum six months. And then we expect the review time of six months. So, we still have high trust in the fact that we can get the product approved at the end of the day.” 

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