Griffin Securities - 07 Apr 2014 - remains BUY, Target $13
Apr 7, 2014 13:01:48 GMT -5
silentbob likes this
Post by otherottawaguy on Apr 7, 2014 13:01:48 GMT -5
MannKind Corp. BUY
Company Update : Pharmaceuticals
FDA Extended Afrezza's PDUFA Date
Please click here for full report, including disclosures.
The FDA has postponed a decision on Afrezza. MannKind announced the agency extended the review period of its inhalable insulin by three months. The news came less than a week after an advisory committee met to assess the merits of the drug and came to a near-unanimous vote in favor of approval.
MannKind is not alone in facing FDA delays. Last August, GlaxoSmithKline indicated that the FDA's Division of Metabolism and Endocrinology Products had extended its review of the GLP-1 agonist albiglutide by three months from January 15, 2014 to April 15th. This is the same division that has postponed Afrezza’s PDUFA date.
Why is the FDA delaying Afrezza? During the recent advisory panel meeting, a member of the FDA stated that the primary reason for the two recent trials was to demonstrate that the two devices MannKind submitted in its NDA were equivalent, and that was the conclusion of the clinical data. In addition, the FDA has reviewed Afrezza since the Company’s first submission in March 2009, so it should be familiar with the drug. Indeed, legal documents show Afrezza was slated for approval in late 2010 until a hedge fund manager wrote a letter objecting to the way the two devices were compared in a bioequivalence study. Finally, labeling and the risk mitigation program for Afrezza were considered at length in the recent advisory panel meeting and their recommendations seemed consistent with MannKind’s proposals and the FDA’s assessment
What is the cost of delays? An answer in dollars and cents is meaningless compared to the lives lost to hypoglycemia. A 20% reduction in low blood sugar levels has been considered a significant target for new antiglycemic drugs. That compares with a 44% reduction in severe hypoglycemia associated with Afrezza in the recent clinical trial involving type 1 diabetics. The American Diabetes Association notes that diabetes claimed the lives of 71,382 people and contributed to another 160,022 deaths in 2007.
A Letter Writing Campaign Has Started, led by an Afrezza trial participant – see: samfinta.blogspot.com
MannKind has sufficient cash into the September quarter, and access to capital to sustain operations further. Just as important, the broad-based support of Afrezza leads us to maintain our BUY recommendation and $13 price target on MNKD shares.
Company Update : Pharmaceuticals
FDA Extended Afrezza's PDUFA Date
Please click here for full report, including disclosures.
The FDA has postponed a decision on Afrezza. MannKind announced the agency extended the review period of its inhalable insulin by three months. The news came less than a week after an advisory committee met to assess the merits of the drug and came to a near-unanimous vote in favor of approval.
MannKind is not alone in facing FDA delays. Last August, GlaxoSmithKline indicated that the FDA's Division of Metabolism and Endocrinology Products had extended its review of the GLP-1 agonist albiglutide by three months from January 15, 2014 to April 15th. This is the same division that has postponed Afrezza’s PDUFA date.
Why is the FDA delaying Afrezza? During the recent advisory panel meeting, a member of the FDA stated that the primary reason for the two recent trials was to demonstrate that the two devices MannKind submitted in its NDA were equivalent, and that was the conclusion of the clinical data. In addition, the FDA has reviewed Afrezza since the Company’s first submission in March 2009, so it should be familiar with the drug. Indeed, legal documents show Afrezza was slated for approval in late 2010 until a hedge fund manager wrote a letter objecting to the way the two devices were compared in a bioequivalence study. Finally, labeling and the risk mitigation program for Afrezza were considered at length in the recent advisory panel meeting and their recommendations seemed consistent with MannKind’s proposals and the FDA’s assessment
What is the cost of delays? An answer in dollars and cents is meaningless compared to the lives lost to hypoglycemia. A 20% reduction in low blood sugar levels has been considered a significant target for new antiglycemic drugs. That compares with a 44% reduction in severe hypoglycemia associated with Afrezza in the recent clinical trial involving type 1 diabetics. The American Diabetes Association notes that diabetes claimed the lives of 71,382 people and contributed to another 160,022 deaths in 2007.
A Letter Writing Campaign Has Started, led by an Afrezza trial participant – see: samfinta.blogspot.com
MannKind has sufficient cash into the September quarter, and access to capital to sustain operations further. Just as important, the broad-based support of Afrezza leads us to maintain our BUY recommendation and $13 price target on MNKD shares.
