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Can some one refresh memory why MNKD's first FDA drug application was denied

ron3637

Mar 21, 2013 11:48PM

Re: Can some one refresh memory why MNKD's first FDA drug application was denied

brentie98

Mar 22, 2013 09:19AM

Re: Can some one refresh memory why MNKD's first FDA drug application was denied

brentie98

Mar 22, 2013 09:35AM

swingtrader88

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Re: Can some one refresh memory why MNKD's first FDA drug application was denied

in response to

Re: Can some one refresh memory why MNKD's first FDA drug application was denied

brentie98

posted on Mar 22, 2013 10:51AM

Only the FDA could come up with clinical utility as the reason for not approving this drug. Let me check 2/3 fewer hypos than existing therapies might satisfy the clinical utility requirement.

Clinical utility is used to keep me too drugs from seeking approval (that plus the $1,000,000 NDA fee). If Al is correct in his assessment of where Afrezza fits into the diabetes drug armamentarium as a first choice drug, we will all look back in hindsight as the first CRL being plain and simple favoritism to big pharma.