The FDA will kill mnkd with the next crl! He will receive this not based of the merits of Afrezza! But it will be demerits base the old Mann's inability to partner or sell mnkd to a reputable Pharma company! Sell, get out, run away with your hair on fire! Afrezza will come to market in maybe another 6 to 8 years. But it will be pickup for nothing and long after Alfred Mann is long gone!
But the evidence remains to the contray.There is still no reason to invest in a company without a cause or a leg to stand on. The retail investor have gone. I am so glad I avoided this fabrication of drug hopeful.
This story is just that now! Nothing will bring a partner or a buyer! The old glue sniffer has over diluted and unpromised on a path! Now ho no longer offer a slight hope! It is done!
Understand this old Mann is done. Expect him to kick long before his bucket list of Afrezza ever gets done!
How can real investors invest on a feeling, reading between the lines and put in words that mankind management couldn't or wouldn't say? What are investors here hoping to accomplish.
Why is Alfred seeking to crush his own stock price? Or is he lying as to partners in the wings of the dark room?
Or he is lying as to partners but can't name one?
If a frog didn't hop? He wouldnt bump his #$%$ every time he hops! The 20,000,000 shares not voted on by shareholders is in violation.mthe CEO only had 350,000,000 authorize shares! Not 370,000,000.
If they had found a partner and with held it! This would be grounds for a massive class action lawsuit. So there is nothing to pump. But CEO did line his pocket with shares that do not exist. You don not get add and additional 20,000,000 shares because your the major shareholder. This is sad situation for shareholders. I glad I avoided this strange company.
My dear investors the hope is completely over. Mankind demise is another win for big Pharma without big bucks! I hope that after a mankind close their doors somebody somebody will pickup the mantle of Afrezza!
The FDA has approved more than thiry diabetic drugs that carry at least 22 seconds of side effects. They would not have put Afrezza on a 6 month review if they were concerned for diabetics. It is a shame for diabetics. They will not approve Afrezza. Big Pharma pay's to keep the FDA open thanks in whole to the GOP.They do protect big business. I'm glad I passed. Our country is in real trouble along with Mankind. Too bad.
Or he has mislead the entire investing community. Silence is not due diligence. I see no partner as the largest reason for another class action lawsuit to be filed I think very soon. I'm glad I passed on mnkd.
The classification of resubmission following a crl is quiet telling in the FDA. A class 1 receives a fast track of 90 days. After two CRL's this should be expected if the FDA had any intention of approval. A class 2 requires a deliberate and intensive study of supplied trial data. This is a warning sign after two previous CRL's. The FDA is now funded by the filing fee and not government as in the past to remain impartial. Their major contributors are the largest Pharma companies in the world. Afrezza has jumped all the FDA bars. They will issue another crl of some obscure technical reason or question to remove any chance of Afrezza to the market. It's potential would have been vast.
Laugh all the way to your poor house. It is interesting at the number of investors here that have not done their home work. I base this upon their post. The fact that Matt has not announce the partner he promised months ago. Also the CEO promise since 2009. All failed bio companies fail for one reason. They never follow threw. A class 2 response to a device equivilant trial is a negative sign right put pd the gate. Afrezza is a great drug. If the FDA cared, they would have receive a class 1 fast track response if they cared more about the diabetic more than their benefactor in large Pharma companies. You may thank our congress for this twist of Government.
A. Applicants should ensure that their resubmissions are clearly marked as resubmissions and that the cover letter for the resubmission clearly states that the applicant considers this submission a complete response to the deficiencies outlined in the previous action letter on the application (i.e., that this submission is indeed a complete response to those deficiencies and is therefore a resubmission.) If the applicant wishes to offer an opinion and the reasons for the opinion on the classification of the resubmission, it may do so in the cover letter.
B. Upon receipt of a resubmission to an action letter, the FDA will determine whether or not the response is a complete response, thereby restarting the review clock, and the appropriate classification of the response. If the FDA does not agree that the submission is a complete response, the applicant will be so informed, and the review clock will not start until a complete response is received.
C. An acknowledgment of receipt letter for the resubmission will be issued within 14 calendar days of receipt of the resubmission stating the classification of the resubmission and the performance goal date.
D. Although the performance goals for acting on Class 1 resubmissions provide for a gradual yearly decrease in time for review, the FDA will complete review and act upon as many Class 1 resubmissions in two months or less as resources permit.
The fact this was only a device equivalent trial is bad news that it requires and additional 6 months. Big Pharma got to the FDA first! This is toast! Regardless of the fact Afrezza is better than any treatment on the market. Money Talks And Great Drug Just Walks! Alfred Mann run down for the last time! Like a bad produce your not sure about letting into the country! You just let is spoil on the dock to remove all doubt!
All of your post are a waste of time. You offer nothing to the discussion of the mnkd and Afrezza outlook. Abusive posting appears to be ans is a waste of time. But it is your keyboards.
Quality Control report
Lyophilized INSULIN Kit 20,000 tests (62INSPEC)
Expiration date : 2015-09-21
Reagents : Lot n°
anti Insulin - cryptate 10A anti Insulin – XL665 11A Insulin calibrator 09A Insulin control 09A Reconstitution buffer 3 07A Diluent 1 15A
Results : Incubation 2h RT
Plate Costar : 96 Half volume (black) Reader : PheraStar
2015/11/15 2015/11/15 2015/09/21 2015/09/21 2015/12/12 2016/02/13
Conc. Ins. (ng/ml)
Std 1 0.312 Std 2 0.625 Std 3 1.25 Std 4 2.5 Std 5 5 Std 6 10
Assay characteristics :
DFmax Accepted Range (rev 3) 14-47
114-266 384 313-570
703-1092 1160 1140-1710
5.0 7.5 10.0 12.5 [Insulin]ng/ml
Lyophilized Insulin kit lot : 11B
Quality control date : 2013-02-20
5 +/- 1 ng/ml ≤ 0.2 ng/ml
Accepted Supervisor’s initials : DL