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Post by factspls88 on Jan 10, 2016 17:09:14 GMT -5
1. Mannkind is in discussions to secure financial health at least through the end of 2017 expects to have commitments by the end of January
2. Mannkind is lowering Afrezza's wholesale price to parity vs. the leading insulin pens effective immediately (or whenever legally allowed with respect to Sanofi's termination.)
3. Mannkind has been in discussions with the major insurance players and has secured agreement from those responsible for 90% of US prescription reimbursements to assign Afrezza tier 2 status as soon as the price adjustment is in effect.
4. Mannkind will submit to the FDA the results of the 2 recent clamp studies to secure an improved label and a designation of "ultra-rapid acting." (assuming these studies have been successful and can be used for such purposes).
5. Mannkind is in the process of securing an professional pharmaceutical contract salesforce for the US and will be put in place at the end of Sanofi's tenure.
6. Mannkind has identified 3 potential advertising agencies for the US market and has requested that they submit pitches for securing Afrezza as a client. Broadcast media advertising will commence as soon as tier 2 insurance coverage is secured and sales personnel have covered physicians responsible for writing 80% of US prescriptions.
7. Mannkind will submit Afrezza for EU approval within the next two weeks.
8. Mannkind will introduce Afrezza into non-EU markets who's only criteria is that Afrezza be FDA approved as soon as contract salesforces can be secured in those markets.
OR
1. Mannkind has secured partnership with Johnson & Johnson (or Google) for the Afrezza brand, effective immediately. As part of the agreement, J&J has agreed to an Afrezza price cut to parity vs. the leading insulin pen brands.
>>>>>>>>>>>
OR
1. If we hear the same old, same old from DeSisto...... I will commit hari kari.
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Post by lakers on Jan 10, 2016 17:35:07 GMT -5
The root cause of Afrezza failure is not having a superior label to land it as Tier 2 without PA, ST and high cost. Sanofi planned to start the superiority trial before the Termination. Mnkd already had trial design figured out using data from Dec early adopter meeting in SD.
While negotiating for the next regional partners (no more all eggs in 1 basket), Mnkd can file a superiority trial w/ FDA immediately. Later Mnkd can transfer the trial to a US partner. Mnkd can better control its destiny that way.
In parallel, Mnkd need to file EU and ME MAA. After the superiority trial finishes with superior result, Mnkd can request for a label change in EU and ME.
I can't be clearer than this, Mr. DeSisto.
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