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Post by mrhaigs on Mar 25, 2014 10:55:11 GMT -5
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Post by biotec on Mar 25, 2014 14:44:06 GMT -5
I also loved that interview, And its not very old.I bet he wanted to mention MNKD but do to the pdufa he bite his tongue.
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Post by BD on Mar 25, 2014 14:47:09 GMT -5
He may not have mentioned it by name, but it's pretty unambiguous what he was thinking about. Unless there's some other inhaled insulin coming on the heels of Exubera...
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Post by babaoriley on Mar 25, 2014 22:49:47 GMT -5
He did everything but admit he, too, went long right before the last CRL!
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Post by cusop on Mar 26, 2014 15:11:18 GMT -5
Hi
I can tell you that one of Insulin formulations that were approved previously, were technically inferior to Technosphere, in particle size distribution, there were issues in maintaining particle size distribution while maintaining the correct pH needed, when the particles activated (dissolved) on and around the lung, this was a problem in the early development of the initial inhaled insulin. yet these products were approved!
The other issue that FDA will face, Is why will any other company waste money developing inhaled therapies for delivery to the lungs if Mannkind is not approved, having met all of the end points. The Adcom will be about the labeling and how to control the implementation of this technology long term.
Note the author mentions inhaled proteins.. another massive market.
Im long.
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Post by mannmade on Mar 26, 2014 18:31:23 GMT -5
Totally agree with you cusp... Especially taken in context of Bill Doub article. Really the worst part will be when the agenda is published. Am sure the AF's of the world will find a way to make it out to be negative. So unless we have a negative or spit adcom vote Wed should be a good day for a rebound in share priceBut we will prevail in the end.... And then if PDUFA is not pushed we should get back on track when approved. If PDUFA is pushed back (depending how far) then I think we are in for some roller coaster rides...
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