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Re: md1225 post# 18163

Saturday, 04/09/2016 12:40:06 PM

Saturday, April 09, 2016 12:40:06 PM

Post# of 32075

Be careful posting like you know what's going on with partnering.


LOL. I am just discussing public info. You are the one purporting to have inside information. But back to the mainline.

SNY was arguable the best candidate to partner with (per MNKD in the post-partnership CC). SNY then drops the product having already made a substantial investment. I find it difficult to beleive that somebody is going to pony up big bucks for something that SNY did not want for free (having already paid).

As far as the EU, what is it worth and when?

The FDA IND does not form a basis for marketing approval. As best we know, SNY never submitted a MMA to the EMEA. Why?

The obvious guess is that the EMEA is unwilling to accept the existing trial data. Certainly the Alfrezza FDA process was torturous. And there can be many reasons for the trial data not translating to the EU.

But even if the present data is good enough, what then? First about a year till approval. Second, they have to run the insurance reimbursement country by country, and this is far worse than here in the States. Given that Alfrezza has a significantly higher manufacturing cost per equivalent dose, the economics could be bad.

Reminds me of DNDN. The drug does work. But the company has dug a hole they might not get out of.
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