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Post# of 251852
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lgonber

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lgonber

Re: lvhd post# 207437

Friday, 12/30/2016 4:44:01 AM

Friday, December 30, 2016 4:44:01 AM

Post# of 251852
CEMP. With this 2 CRLs and asking for a 9K patient safety study in CABP patients, FDA has put things very difficult for soli approval IMO. I believe future relies on what Europe will do and also what are the probability of Gono indication approval. What are the real chances of Soli to be approved in Europe? will EMA follow FDA or will approve with restrictions (bear in mind Ketek is used in Europe in several indications). Also what are the possibilities of Soli to be approved for Gono given it is only one dose and safety issues are mitigated for this indication? These are the 2 key factors for CEMP IMO.
If Soli is approved n Europe and Japan and if gone indication is successful, there is hope, if not...
Any comments? thanks
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