MannKind Delays NDA and other news
Late yesterday MannKind (NASDAQ:MNKD) announced the NDA filing for AFRESA®, their inhaled insulin, would be delayed by three weeks. According to a company issued press release; “The document is fully drafted. However, we decided during our final review that it would be preferable to remove several tens of thousands of pages of back-up data from the submission and instead make this material available to the FDA upon request. This change will significantly reduce the size of the NDA and should make the NDA more reviewer-friendly.”
While Diabetic Investor understands the need for expediency the people at MannKind better hope that the FDA does not their press release. Call us just a bit skeptical but we’re not exactly sure it’s wise to tell the agency that you have removed “several tens of thousands of pages of back-up data”. Human nature being what is this statement just might peck the agency’s curiosity and create the impression that there might be something in those tens of thousands of pages that the company does not want the agency to see. It would be natural then for the agency to ask the company to provide these tens of thousands of pages which would further delay the approval process.
In the end it really won’t matter much as even if approved AFRESA® is a product with limited potential. Since the day Exubera was pulled from the market the company has been scrambling to reinvent itself, desperately telling everyone that AFRESA® is a better insulin that just happens to be delivered with an inhaler. During each conference call the company speaks optimistically that a partnership is just around the corner and once the product is approved offers will come tumbling in. The reality is that if nothing else the company is the victim of bad timing. As Diabetic Investor pointed out when after the company’s most recent earnings call the time for inhaled insulin has come and gone.
In other news Harvard Medical School, those wonderful folks who told us that there was a possible correlation between the size of woman’s butt and diabetes, have come up with another earth shattering piece of news that diabetic pregnant woman are more likely to be depressed. According to a story posted on the Washington news web site;
“Harvard’s Katy Backes Kozhimannil, MPA, also of Harvard Pilgrim Health Care, studied low-income women to explore a link between diabetes and depression during and after pregnancy.
The Boston researchers found that, regardless of age or race, women with any form of diabetes were almost twice as likely to be clinically depressed than women without the disease. The study analyzed data from the perinatal period – usually the third trimester of pregnancy and the year following delivery.
Given the fact that as of yet men cannot become pregnant Diabetic Investor won’t rant about the rampant sexism in diabetes research. However, we do wonder why an institution as respected as Harvard is spending so much time and money on these studies looking at woman and diabetes. Are men with diabetes not worthy of study?
As far as this most recent study goes Diabetic Investor could have saved Harvard the time and effort by asking anyone who’s lived with a pregnant woman, diabetic or not, that pregnancy as wonderful as it is, is not exactly an enjoyable event for any woman. The fact that pregnant woman experience depression is hardly earth shattering news considering what a woman’s body goes through during the pregnancy, an event which is topped off with the painful experience of actually delivering the baby. After witnessing such an event Diabetic Investor can state with confidence this one time all the men in the world feel very fortunate they do not have the ability to get pregnant.
But at least all of us can rest easy that Harvard has discovered woman with diabetes experience depression. Combined with their other amazing research on the size of a woman’s butt and diabetes perhaps Harvard can now move on to such mundane matters as doing some research on what to them must seem like trivial matters like why people actually develop diabetes or more effective methods for treating diabetes. We realize these matters are not as exciting as pregnancy and diabetes, butt size and diabetes or breast size and diabetes yet somehow we believe the millions of people with diabetes and the millions more with pre-diabetes would be thankful for such mundane research.