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Post by peppy on Dec 5, 2015 13:26:55 GMT -5
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Post by metaboman on Dec 11, 2015 11:47:11 GMT -5
Again very informative. Does anyone know if and when MannKing/Sanofi have applied for Afrezza approval to the EMA? And or what part of the process it is at?
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Post by lakers on Dec 15, 2015 3:23:10 GMT -5
Page 39 of 41 shows nice timeline. The assessment of an application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is interrupted by at least one ‘clock-stop’ during which time the applicant prepares the answers to questions from the CHMP. The clock stop happens after day 120 and may also happen after day 180, when the CHMP has adopted a list of questions or outstanding issues to be addressed by the company. Related discussions are listed in the agenda under sections 3.2 (Day 180 List of outstanding issues) and 3.3 (Day 120 list of questions). CHMP discussions may also occur at any other stage of the evaluation, and these are listed under section 3.4, update on ongoing new applications for centralised procedures. The assessment leads to an opinion from the CHMP by day 210. Following a CHMP opinion the European Commission takes usually 67 days to issue a legally binding decision (i.e. by day 277 of the procedure). CHMP discussions on products that have received a CHMP opinion and are awaiting a decision are listed under section 3.6, products in the decision making phase. www.ema.europa.eu/docs/en_GB/document_library/Agenda/2015/12/WC500198841.pdfDates 12/14/15 |
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Post by mnholdem on Dec 15, 2015 7:35:58 GMT -5
This is the process map found on page 39:
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Post by peppy on Dec 15, 2015 7:55:32 GMT -5
This is the process map found on page 39:
Do we have any idea, where Sanofi/MNKD are in this process?
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Post by mnholdem on Dec 15, 2015 8:31:23 GMT -5
No. The only remarks made publicly by either company refer only to Sanofi's pre-submission planning.
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Post by lakers on Dec 15, 2015 11:51:49 GMT -5
No. The only remarks made publicly by either company refer only to Sanofi's pre-submission planning. 1Q16: EU, ME MAA submissions. A well-prepared submission is normally approved faster. A reasonable effort includes international expansion in major Territories. The rumors of early partnership termination is greatly exaggerated. |
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