Post by liane on Dec 1, 2013 16:54:02 GMT -5
Positive mention in MF. Not the most thorough or accurate DD, but these days I'll take anything positive.
www.fool.com/investing/general/2013/12/01/5-potential-fda-approvals-that-may-change-millions.aspx
Afrezza
With a PDUFA goal date of April 15, MannKind's (NASDAQ: MNKD ) inhaled insulin drug, Afrezza, which could be used to treat type 1 and type 2 diabetes, is certainly an experimental therapy with a ton of potential.
The road to a possible approval hasn't been easy for Afrezza, with the FDA rejecting it in 2010 because of concerns about its efficacy and its delivery device. With a completely new device known as the Dreamboat, which replaced its MedTone inhaler, as well as fresh phase 3 data showing a superior reduction in A1C levels relative to the placebo, the possibility of a more convenient and pain-free glucose control therapy is well within reach. Clearly, price point could be a stumbling block, as well as tempered analyst expectations, but the potential market for Afrezza, assuming an approval, could be bigger than Wall Street analysts are predicting.
www.fool.com/investing/general/2013/12/01/5-potential-fda-approvals-that-may-change-millions.aspx
Afrezza
With a PDUFA goal date of April 15, MannKind's (NASDAQ: MNKD ) inhaled insulin drug, Afrezza, which could be used to treat type 1 and type 2 diabetes, is certainly an experimental therapy with a ton of potential.
The road to a possible approval hasn't been easy for Afrezza, with the FDA rejecting it in 2010 because of concerns about its efficacy and its delivery device. With a completely new device known as the Dreamboat, which replaced its MedTone inhaler, as well as fresh phase 3 data showing a superior reduction in A1C levels relative to the placebo, the possibility of a more convenient and pain-free glucose control therapy is well within reach. Clearly, price point could be a stumbling block, as well as tempered analyst expectations, but the potential market for Afrezza, assuming an approval, could be bigger than Wall Street analysts are predicting.