I am bumping this AUGUST 22, 2013 post since PFG was finally smart enough to read the part in the briefing docs last week where the FDA admitted they had prior issues with insufficient efficacy data with the Medtone inhaler.
I tried telling PFG and others that 171 was poor because it was just as bad if not worse than Trial 009 which used Medtone C but of course no one listened to me and only called me a liar.
Now PFG is trying to say MNKD or the FDA never warned him that they had prior problems with Afrezza efficacy!!! All you had to do PFG was listen to me back then. I was trying to help you. Instead you chose to call me a liar. Now you act surprised that the FDA had issues with efficacy. LMFAO.
I tried telling you folks this a YEAR AGO. If you spend less time calling me a liar and more time comprehending what I was telling you, you'd ALL have a lot more money in your pocket today. Including you OPC.
I was only trying to help, not hurt. You may have a lot less money now, but at least you were able to call me liar when I tried to warn you. PFG and OPC, you should be proud of yourselves.
Why don't you go to MNKD's website and you will see that it didn't fail. Here are the notes from their website:
Study 171 was an open-label study involving 518 patients with type 1 diabetes on basal/bolus insulin therapy who were studied at sites in the United States, Russia, Ukraine and Brazil. After a four-week run-in period to optimize their basal insulin, patients entered a 24-week treatment period in which they were randomized in one of three ways:
Continuing on subcutaneous insulin aspart in combination with a basal insulin (170 patients);
Switching to AFREZZA administered using the Gen2 inhaler in combination with their basal insulin (174 patients); or
Switching to AFREZZA administered using the MedTone inhaler in combination with their basal insulin (174 patients).
The treatment period consisted of 12 weeks of prandial insulin optimization with continued basal titration followed by a 12-week period during which subjects maintained stable doses of insulin (prandial and basal). There was also a follow-up visit four weeks after completion of the treatment period.
Over the 24-week treatment period of this study, A1c levels decreased comparably in the AFREZZA-Gen2 group (-0.21%) and the insulin aspart group (-0.40%). The 95% confidence interval (0.02% to 0.36%) of the between-group difference did not exceed the predetermined threshold of 0.40%, thereby establishing non-inferiority between AFREZZA-Gen2 and insulin aspart, which was the primary endpoint of the study.
Sentiment: Strong Buy
009 did, even though MNKD called it a success and made a big deal about it reaching the primary non-inferiority endpoint. But the FDA still had an "A1c issue with it" per Al Mann.
009 was better than 171 so what do you think. We'll let the FDA decide that question.
Oh the silly "Rapp the Liar" is back. He just keeps pumping lies, and then when confronted and proven wrong, runs and tries to claim something else. What a sad way to spend one's day. Lying to others. Oh well, if it makes him feel good, I guess that is all that counts...LOL
Lol do not listen to the proven liar on this MB. Read the press release on Mannkind's website, or listen to the conference call discussing the trial results also available on their website. Both trials hit all stated requirements for FDA approval and they confirmed that there are no safety issues, and management repeated over and over that they are very pleased with the results.
Which is why they are getting the second tranch. And why they are posting new jobs in anticipation of production rampup. And why they hired a firm to help broker a partnership agreement with a larger company.
Listen to Al Mann himself say "they're crazy" about the people who are spreading rumors that the trials failed or the drug does not work.
There is a concept called "necessary, but not sufficient." As bright as you are, you should know the difference.
You think Deerfield and the FDA follow the same standard? You believe everything Al Mann says? He doesn't. He wouldn't have just paid out millions in a class action settlement if he did. He would have better defended the allegations.
That's open to interpretation depending on how you define success/failure.
believe it or not mnkd, institutions, fda, investors all have different standards.
if you want to know whether the investors' sentiment towards whether 171 is a failure or not, please check the stock price since the announcement of the results......
If the market truly believed either trial was a failure, the stock price would be $1 - if that. If you want to use the market as an indicator, I'd say it's a resounding vote of confidence that with all the FUD running around, we are still maintaining ANY value. If RAPP and other liars were correct, and the SCIENTIFIC community bought their garbage, we'd be at $1 or less. End of story.
You should never investment based upon what other people believe. Do your own due diligence. You make money by buying low and selling high. You cannot accomplish and maximize that goal by following the crowd. Also, if you do not believe in market manipulation, then I suggest you go educate yourself, before you invest anymore of your money in the market. In my opinion, your entire comment is silly, and that of a naïve investor...
A severely manipulated price, time will tell Brother,and you will Fry like Kentucky Fried Chicken. The study was an FDA monitored and approved success, you can't just make this stuff up.... All Endpoints were met as overseen by the FDA.......
Sentiment: Strong Buy