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Biotech / Medical : Regeneron Pharmaceuticals
REGN 766.82+1.5%3:34 PM EST
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To: Miljenko Zuanic who wrote (1961)11/4/2016 3:30:40 PM
From: Miljenko Zuanic   of 3559
 
Leo: (at CC)
<It is only been a week since we received the complete response letter and we are preparing to engage in meaningful discussions with the FDA, so it is too early for us to comment on the expected timeline for a potential Sarilumab approval.>
<We can summarize by saying that Sanofi is working very hard and they believe they can quickly remedy the deficiencies that were not related to Sarilumab per say, but rather some general GMP deficiencies, which there frankly and well on their way to remedy of course we have to work with the agency and they have to be satisfied.>

<In terms of products that are already manufactured there. I think you should think the FDA sort of takes a risk based approach here, they have sort of maybe frozen in place those things that are actually being - assuming that they don’t think a plant is way out of whack. And nothing can be shipped and still they continued to fill an used product from that facility for approved products.
It’s a new product such as Sarilumab, which gets sort of shout off obviously and unfortunately. We are working with them on Sarilumab and we are also working with a different group on Dupixent, which is a breakthrough product, which has a whole different set of approaches to it.>

As usually they are BULLSHITING with FDA and with answers to questions. 483 was on 7/19/16...3-4 months is plenty of time to do something. To show FDA that they (if problems not severe) are out to fix CGMP problems!
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