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Post by bioexec25 on Feb 17, 2016 8:38:58 GMT -5
Bthomas - We did a similar thing with Tamiflu back in the day with Roche when Gild needed cash to fund HIV dev. Regional rights for larger up cash, used to fund marketing efforts in other regions. Funny now to think about Gild needing cash. Lol. GLTA
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Post by kball on Feb 17, 2016 8:52:20 GMT -5
Bthomas - We did a similar thing with Tamiflu back in the day with Roche when Gild needed cash to fund HIV dev. Regional rights for larger up cash, used to fund marketing efforts in other regions. Funny now to think about Gild needing cash. Lol. GLTATrying to remember, a news story i saw about a week ago that i think said GILD has about 23 billion in cash now.
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Post by kbrion77 on Feb 17, 2016 8:53:16 GMT -5
Bthomas - We did a similar thing with Tamiflu back in the day with Roche when Gild needed cash to fund HIV dev. Regional rights for larger up cash, used to fund marketing efforts in other regions. Funny now to think about Gild needing cash. Lol. GLTA Like Apple in 97. Time to get creative Matt.
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Post by kc on Feb 17, 2016 10:23:04 GMT -5
Bthomas - We did a similar thing with Tamiflu back in the day with Roche when Gild needed cash to fund HIV dev. Regional rights for larger up cash, used to fund marketing efforts in other regions. Funny now to think about Gild needing cash. Lol. GLTATrying to remember, a news story i saw about a week ago that i think said GILD has about 23 billion in cash now. I would gladly take GILD stock in exchange for MNKD. In Fact I do own some GILD already. They could do a half cash and half stock deal. I bet they could take Technospere to a new level with their research.
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Post by peppy on Feb 23, 2016 13:26:11 GMT -5
EU approvals are cut and dried. The file goes to the European Medicines Agency who then has 210 days to act on the file unless there is a "clock stop". A clock stop happens if there are technical questions that cannot be answered quickly, and in theory a clock stop can go on forever, but most are relatively brief. If EMA recommends approval, the recommendation goes to the EU Parliament for final action, a process that takes 60 days. So a normal EU approval process is 210+60 = 270 days which is the same as for FDA. What you don't see is the back and forth between two rapporteurs, who are country representatives on the Committee for Human Medicinal Products and the sponsor. The rapporteurs go around and get informal advice and guidance from the EMA, solicit opinions from other committee members, and so on as a way to identify speed bumps. Many times the sponsor will work to address any open issues identified informally BEFORE the file is submitted (FDA is also good about giving helpful advice to those that want to listen). What we can't know is whether Sanofi began the informal consultation with the rapporteurs and, if they did, what feedback they got. Sanofi certainly had enough time to get a non-controversial product through the process so there may have been some unaddressed concerns. What is the price tag? Any idea of the price ($$) paid along the way?
The price tag: the standard new drug filing fee of $2.4 million. FYI
www.raps.org/Regulatory-Focus/News/2016/02/22/24378/Sanofi-Redeems-245M-Priority-Review-Voucher-for-Type-2-Diabetes-Treatment/#sthash.6LLx8hUO.dpuf
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