FDA v MNKD BD

[jefferson]

First of all, what's up everybody. I've been following proboards and agoracom and YMB FOREVER, and feel like I know a lot of you because I read your thoughts every day, and have for so long. So, thanks to all you guys for your awesome research, you have served a lot of people that are the silent majority.

Maybe I'm crazy, but I feel like undid as much DD as I could, and I'm going to ride or die with my investment. I made a nice chunk before the trial results were announced and maybe should have called it good then but didn't. Fridays BD caught me like a lot of you pretty flat footed. The thing I keep talking about with my friends is the glimmer of hope that I (we) have in that Al is a billionaire who knows a shit ton more than Fuckstain about diabetes, and has the track record to prove it. So maybe tomorrow will be mnkd's day to flip a serious bird to the haters. My hope is that they weren't caught as flat footed as us. They BETTER not have been!

In my voracious reading of everything I can possibly digest, I haven't heard anyone compare the FDA's BD to mannkind's. Are there any points in the mannkind document that we can glean as a defense against the FDA bd? I hope that tomorrow our team comes correct!

-no hedging, no calls/puts/options... 100% committed. Go MNKD, and good luck y'all!

[alcc]

I scanned through the company's doc. Looks like a rehash of what I had seen before. Does not appear like a response to the FDA doc. I guess they did not get a courtesy early copy.

[nadathing]

This was an emotional roller coaster. If there are any emotions tomorrow it should be the panel having empathy for the millions of us that suffer with diabetes. Is Afrezza safe? It has shown to be. Is it effective? Maybe not as much as Al stated it was, but it should be close enough. As an alternative means of treatment it should be approved IMO. I truly think it will lead to greater compliance to treatment, but some feel that is not a factor in determining approval.

[jpg]

Mar 31, 2014 17:15:44 GMT -5 nadathing said:

This was an emotional roller coaster. If there are any emotions tomorrow it should be the panel having empathy for the millions of us that suffer with diabetes. Is Afrezza safe? It has shown to be. Is it effective? Maybe not as much as Al stated it was, but it should be close enough. As an alternative means of treatment it should be approved IMO. I truly think it will lead to greater compliance to treatment, but some feel that is not a factor in determining approval.

I would say compliance to treatment is HUGE with clinicians, pharma and the FDA. Treating patients who don't take their treatments for whatever reasons is one of the biggest problems we have. Once a day pills have been a game changer for compliance in many chronic disease. Cost is obviously a big one also...

[ezrasfund]

Compliance is very important, and Ms Hamburg at the FDA knows it best. The most important work of her career, and probably what got her the job at the FDA was her work as NYC health commissioner. From the FDA website "Her most celebrated achievement was curbing the spread of tuberculosis, which resurged as a major public health threat in the 1990s. As a result of Dr. Hamburg’s reforms, New York City’s TB rate fell significantly over a five-year span. Her innovative approach, which included sending health care workers to patients’ homes to make sure they completed the drug regimen, is now a model for health departments worldwide."

But that story is just something to distract from the fear, uncertainty and dread of the last few days. IMO the letter from the DiaTribe editors says it all, and most eloquently. I have not sold off any of my shares or calls. Thanks to this board and the other resources out there I feel I am better informed about Afrezza than most of the pundits, and I find myself strangely calm going into the AdCom and FDA decision, considering how much I have riding on the outcome.