FDA Released Postmarket Requirement/Commitment Number 4

[sayhey24]

Maybe its as simple as they have not had enough "collected and independently adjudicated major adverse cardiovascular events" in four years to do a study. It would not surprise me. Afrezza stops the post meal BG spike which is like a stake in the heart.

I would expect fewer cardiovascular events, flat as worse case, overall improved vascular health and flat to improved pulmonary function. What BP wants afrezza to show results like that? There is probably plenty of pressure on the FDA to cancel the whole damn thing. Afrezza study results when properly presented will always out-perform all other treatments.

[mango]

Dear James,

For any additional information regarding closed PMCs and PMRs, you must submit a Freedom of Information Act (FOI) request. 
I’ve provided the link below to the FDA web page where you will find a request form.

www.fda.gov/regulatoryinformation/foi/default.htm


Respectfully,
 
Kathy
 
Kathy Well
Science Policy Analyst (PMRs/PMCs)
CDER | OND | IO | SPRT
Silver Spring, MD

[tomtabb]

If the changes were significant, I would think MNKD would issue a press release to that effect, wouldn't they?

[mango]

Nov 28, 2018 8:35:45 GMT -5 tomtabb said:

If the changes were significant, I would think MNKD would issue a press release to that effect, wouldn't they?

I don't know, why don't you ask them?

[mango]

Let's ask Mister Ed instead?

[factspls88]

Nov 28, 2018 9:39:29 GMT -5 mango said:

Let's ask Mister Ed instead?

Of course!