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Post by hawaiiguy42 on Aug 1, 2016 5:59:10 GMT -5
Jun 16: MannKind intends to seek regional partnerships for development and commercialization of AFREZZA in foreign jurisdictions where there are appropriate commercial opportunities. In order to commercially market AFREZZA in the US and elsewhere, MannKind also needs to develop an internal sales team and expand their marketing infrastructure, collaborate with third parties who have greater sales and marketing capabilities, and/or purchase services from a contract commercial organization. Link: www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4631Development and Regulatory status UK: Phase III Clinical Trials EU: Phase III Clinical Trials US: Launched UK launch Plans: Available only to registered users Actual UK launch date: No actual UK launch date noted, but I'll keep checking.  |
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Post by matt on Aug 1, 2016 7:01:27 GMT -5
Mannkind first has to get an EMA approval. While, in theory, obtaining a national approval (i.e. UK only) is still possible, virtually no drugs have been approved in the past ten years on a national basis because the effort is almost identical to going through the central procedure at EMA, and success there gives access to 28 countries. The process is similar to FDA, and takes a minimum of 270 days after the application is actually filed.
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Post by mnholdem on Aug 1, 2016 11:15:19 GMT -5
Is the EMA Centralized Authorization process a function of the European Union or does it pre-date it? I was just wondering whether brexit will have any impact on Great Britain's relationship with the EMA. I suspect not, but I'm not 100% certain.  |
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Post by agedhippie on Aug 1, 2016 11:23:14 GMT -5
Is the EMA Centralized Authorization process a function of the European Union or does it pre-date it? I was just wondering whether brexit will have any impact on Great Britain's relationship with the EMA... It's an EU entity but is broader than just the EU. It would be very unlikely that the UK would decline to join the EMA since they lack most of that function now and would want to be members of the EFTA. |
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Post by audiomr on Aug 1, 2016 17:23:33 GMT -5
Jun 16: MannKind intends to seek regional partnerships for development and commercialization of AFREZZA in foreign jurisdictions where there are appropriate commercial opportunities. In order to commercially market AFREZZA in the US and elsewhere, MannKind also needs to develop an internal sales team and expand their marketing infrastructure, collaborate with third parties who have greater sales and marketing capabilities, and/or purchase services from a contract commercial organization. Link: www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4631Development and Regulatory status UK: Phase III Clinical Trials EU: Phase III Clinical Trials US: Launched UK launch Plans: Available only to registered users Actual UK launch date: No actual UK launch date noted, but I'll keep checking. This has been up for many, many months. Don't know the significance at this point. Would be nice to know exactly what the reference trials are. |
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