CDER DRUG INFO
Today at 11:32 AM
Thank you for writing to the Division of Drug Information in the Center for Drug Evaluation and Research (CDER).
Your message regarding Afrezza is much appreciated and makes the needs and desires of patients and their families very clear. However, please understand that under the law (21 CFR 314.430), FDA cannot comment on drugs pending approval as this information is considered confidential for the company. FDA is committed to providing timely access to potentially useful medical treatments for seriously ill patients, as well as to working for speedy approval of new drug products while maintaining high, scientifically based, safety and efficacy standards.
Thank you again for taking the time to write to us.
Drug Information Specialist
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administrationpe message
Come on Kevin, take a pill. Go visit some friends and family for 90 days. Writing the FDA will not help. If that worked, every short monkey and Martin Shkreli wanabe would be doing it too trying to tip the scales.
Do you know how embarrassing this e-mail is?
Here we have an investor who writes to the FDA to hasten the approval of a drug for which he will gain big investment bucks. The recipient (FDA) has already made up its mind to delay. The FDA is a large monolithic government agency who really cares squat about the individual. They will not change their mind.
But Kevin thinks the FDA actually read his e-mail and personalized a response to him. It's like believing a blow up doll really has love for its owner.
FDA, DEA, EPA, Dept. of education, Dept. of energy.
All have outreached their authority. All are more costly than their results warrant. All would be cut under my administration.
Sentiment: Strong Buy
Unfortunately, they are untouchable. Just like the rest of the Obama administration, i.e., IRS, Eric Holder, Hillary (Benghazi), Fast and Furious. Wake up and stop living in dreamland. And...relax, MNKD will succeed. Can you imagine the egg on FDA's face if they were not to approve, especially after billions are made in foreign markets and Afrezza is a proven life saver in those countries.
Interesting.......Specifically the sentence that reads: FDA cannot comment on drugs "pending approval". Why would they choose to word it that way? Why not "FDA cannot comment on drugs currently in the regulatory review process"? hmmm......
I am long too, but read the last sentence! A short could cherry pick that comment as well. Basically, a form letter. I wish we could read into it as I haven't sold a share, in fact added yesterday, and have some dry powder for any other drops!
Sentiment: Strong Buy
benir21 you got it right :) I have seen other responses from the FDA mostly boiler plate, but this response was handled from an individual at the FDA and pending approval was inserted in the comments instead of just saying drugs under review. Thanks for pointing it out and good luck.
I think you're reading a bit too much into that. The letter is likely nothing more than the typical generic response letter to ANY inquiry such as this. But I do believe approval is forthcoming!