Lifo, you want facts? How about one straight from the horse's mouth a few days ago:
"We cannot predict when, if ever, we may conclude an agreement with a partner. There can be no assurance that any such collaboration will be available to us on a timely basis or on acceptable terms, if at all."
You are a genius.
You geniuses are ignoring the second sentence in this brilliant post: "Lets assume Affinity 1 proves bio-equivalence . . ."
This didn't happen. If anything, Affinity 1 proved that the two inhalers are not bio equivalent, and the old safety data will not be imputed to Dreamboat. Without this, no approval. Sorry.
Read the entire post next time smart guys.
His game is simple. He posted five years ago on this board that he has well over 50,000 shares of MNKD at a DCA above the current share price. So it's clear he has lost his behind on this stock. So to make his money back, he creates a new board and sabotages this one with multiple ID's in an effort to shift subscribers to his own board for for personal gain. Not to mention the daily plugs on here. He incites passions with fake ID's, then directs people to his new board. Marketing for dummies 101.
It's not a bad idea if you think about it. I'm curious to know how much money he is making off of that new gig. He banned me a while ago, so I'm not able to see what sort of ads he's been able to generate. But I'm sure he's making something.
If I made such a dumb investment in MNKD and lost as much money has he did, I'd try to recoup my investment in other ways as well. If he's smart, he's probably shorting MNKD now, but I doubt it. He has some sort of sick obsession with this company. I doubt he has the trigger to short this animal. He seems like a loyal lad.
Whether you like him or hate him, you must admire his maddening brilliance. A little unorthodox, but pretty clever.
Why is everyone so shocked that MGMT is being exposed as liars? Is everyone just now starting to realize that this product will never be approved? MNKD has NO IDEA how to prove bio equivalence to the FDA. Medtone is a much better inhaler than Dreamboat and bio equivalence will never be proven without the results from the recent 30U trials . . . if ever. Regardless, the FDA will not approve Dreamboat since MNKD has already developed a safer and more efficacous inhaler in Medtone.
MNKD has always mentioned that the product was safe and has never needed an advisory panel. Yet now they are hinting that there may be one. Al said pre data that the CV risk ratios would be updated after the trials. Where are they? Is CV risk over 1.03 post Affinity? Why the need for a panel? No bio equivalence? No bridge to all the old safety data? The FEV1 values too divergent between inhalers? A1c's too divergent? Or is there simply insufficient data comparing PAR DOSING between inhalers?
MNKD told everyone that they "worked very closely" with the FDA on the design of the Affinity trials after the second CRL but admitted in the recent 10Q filing that they have no idea if the FDA would even find their "approach to the clinical trials acceptable." Are you kidding me? They are trying to cover their ass now? It's too late for that. Another Class Action is on the way.
I warned everyone on the day of the results that this product would never get approved. Why are you folks just starting to realize that I was right? It took you three months and a near 50% reduction from the 8/14 highs to realize this?
Dreamboat inhaler failed. Also, a net 3.5 pd weight gain will prohibit a label expansion for Type 2s. IMO the FDA will NEVER approve a product than causes such weight gain, CV risk and decreased lung function in a Type 2 population. No way.
You people need to get a clue. You should have done it at 8.60 like me.
Clevans, are you kidding? Can you not read the PR's from the Affinity trials for yourself? Medtone had better A1c efficacy than Dreamboat. Medtone had less cough than Dreamboat. Medtone had had better FEV1 results than Dreamboat, which when coupled with the .08 A1c differential, it's is actually much more divergent than most people yet realize. But the FDA understands it. The FDA understand that the true FEV1 differential between the two inhalers will be measured from par efficacy, not from a .08 differential standpoint. You can bet on that.
Trial 171 proved that the Medtone inhaler does a more efficient job than Dreamboat at getting the insulin past the lungs and into the bloodstream for use . . which is forcing the lungs have to work harder to draw similar amounts of insulin. Of course, MNKD has yet to do the necessary 30U head to head trials to prove this, hint hint, but If you think about it, this is understandable considering it is a smaller device. MNKD has also yet to update the 1.03 or under CV risk parameters which have likely changed quite a bit with the newer and less efficient Dreamboat inhaler. But who of us care about CV risk ratios? It's only the most important factor that the FDA will consider. Funny how we've heard nothing about it.
If I am right, and I am, a safety bridge will not be established. With no bridge, no approval. The FDA will not even do a clinical utility analysis until a bridge (bio equivalence) is proven.
Clevans, those are the terms the FDA uses, not me. The first CRL used the term clinical utility (which basically means the rewards don't outweigh the risk when considering what's already on the market). The 2nd CRL used the term bio equivalence. I don't define them. The FDA does. The third NDA will be dealing with both issues again, front and center.
MNKD finally getting around to admitting what I've been posting here since data release on 8/14. No bio equivalence or clinical utility = no FDA approval. No approval = no partnership.
Not only is Medtone a much better --- and much different --- inhaler than Dreamboat, but there are more efficacious insulin options with fewer health risks for managing diabetes already on the market.
The FDA knows this and MNKD is finally getting around to admitting it to its shareholders. Sad for those who held onto shares after 8/14.
Paul (ajohntool), the depths of your brilliance (i.e. madness) are really quite intriguing. Interestingly enough, I feel like this community has only scratched the surface of your insanity.
Adding the word "tool" to your 210 posts doesn't make you any less OPC. It does however add some nice flavor to yet another alter ego. I like it. Very impressive. I'll buy "you" a drink as well.
Hey oppie/ajohn32/chris, I thought Rapp accurately predicted every move from this company? Too bad you couldn't be him also. What would a psychiatrist find if they tried to unravel that sick mind of yours?
I personally find you (and by "you" I mean all of your identities) to be extremely fascinating. But I happen to like psychopaths.
If you ever leave Bedford and head a little south, I'd love to buy you a drink. But only one of you. Even though I made a good bit of money on MNKD, buying rounds for all of "you" could get quite costly.
Such a brilliant post. Please keep bumping. It's faith and confidence in Mnkd shows what a believer I was prior to 8/14. The post contained only two assumptions: 1) bio = would be proven in
171 and 2) 175 would exceed expectations. Neither happened. Bio = wasn't proven (it was dis-proven IMO) and 175 not only failed to exceed expectations (1.0 or higher) but it failed to meet them with a .4. Those two failed assumptions caused me to sell 95% of my position on morning of 8/14. Glad I did.
Joe Springer also said in his "5 Reasons Mannkind Could Be . . . " article that Afrezza needed to show superior results over placebo in 175 and that "Afrezza needs to show .5% improvement in HbA1c to be superior." Joe went on to say that "this should not be a problem."
We all know that didn't happen. So Joe was wrong. Or perhaps MNKD was wrong when it backtracked and said a .5 wasn't needed for superiority. (Although they could both be right if FDA does not approve. I happen to think MNKD and Joe were right when they said Afrezza needed to show superiority and superiority was defined by a .5 improvement).
Regardless, I actually agree with Joe in that Merck will be the partner IF Afrezza is approved, but I don't think Merck will sign a deal unless and until Afrezza gets approval.
I'm on record saying no approval. Thus no Merck partnership.
That's funny OPC. Considering most of your "moderators" are actually you in disguise. For the one that isn't, did you tell your mother that you banned me b/c you could no longer stand how Rapp was always right?
BTW, how did I manage to earn well over 200% in 6 months while "bashing" the stock? Maybe you should have listened more instead of putting me on ignore. Putting me on ignore seems like a costly proposition. I told everyone who read my posts since May exactly how, why and what would happen to the data on August 14th and to the stock price post 8/14.
OPC was long over 20k shares in 2009 when he was filling add'l orders at 5.15. If he DCA'd around 5.15 and MNKD closes at current price of 5.18 today, he would be up .006% on his investment.
.006% may sound like a great return for many of you (this is sarcasm), but considering he bought back in 2009, you're looking at an annualized return of about .001%. Wow. What a 4 year return! This lady OPC really knows how to make money.
The following are posts from OPC from back in 2009 when he was calling others #$%$ and begging for a price of 5.15 so his orders could fill. Wow. He's made a lot of money over the past 4 years since considering the pps is still 5.15 today. LMFAO. I guess it hasn't quite reached the 20 to 25 level he was expecting.
opc11 • Nov 2, 2009 6:57 PM
I don't really care if you believe me. On 10/29 I was filled for 400 shares at $5.15. Today I was filled for 4437 shares at $5.15. Now, #$%$. That's two out of the last 3 trading days, each of which had a low of $5.15 and I got filled on both days.
opc11 • Nov 3, 2009 3:54 PM
Hillarious! Thanks for the laugh. I've said it a dozen times. I'm very long and I want the price to drop so I can buy more. If we don't get back to 5.15 I'm going to be quite upset knowing that a .01 stood between me and a whole lot more profits when this thing hits 20 or 25.
opc11 • Oct 29, 2009 4:55 PM
Please, Shorts, drive the price down further! I only got a portion of my order filled today at $5.15
opc11 • Nov 2, 2009 11:16 AM
Yes. I'm very long and hoping to get more long. I just would like to purchase at a lower price. So for the last few days I've been routing for the shorts! I got about 400 more shares at 5.15 last week and got a couple thousand filled this morning. Still hoping the rest of my orders are filled today.
opc11 • Nov 4, 2009 4:38 PM
come onnnnnnnn $5.15!
opc11 • Nov 3, 2009 4:18 PM
I'm long 20,537 shares. How about you?
He's still got a way to go before he reaches OPC's 5000 posts in 4 years.
I was reading some of OPC's posts from 2009 where he was begging the stock to come back down to 5.15 so he could load up more shares.
He got he wish. 4 years later. LMFAO. Funniest #$%$ ever.
Wrong about data? Haha. I was right about the data and you can't stand it. You can't stand that I bought at 2.30 in Feb and sold over 8.60 on 8/14 when I read the data and warned on this board at 10:40 that morning that the FDA may not interpret the results as a success.
You can't stand that Summer Street, Adam F and others picked up on what I was saying of the data and published articles about it in the following days after my posts. You can't stand that you held on after I warned you that the data was bad over 2 months ago. You can't stand that you are down 40% since I sold.
You can't stand that I was right about the meal escalation study. You can't stand how I was right about how MNKD's increased basal titration theory would not work. You can't stand how I was right about the studies meeting endpoints and being called a success, yet having unanswered questions re bio = and clinical utility that would cause a drop in the pps. You can't stand how MNKD had to file an 8k as a reaction to me after I called them out on 8/15 for not publishing their Medtone data.
You can't stand how I went on your board and called you out for being the dull brained idiot you are. When you couldn't take the hits to your ego any longer you banned me from your silly board before I could even respond to your lies.
Your board is what happens when men (IF you are one, which I highly doubt. Your posts sound more like a whiny, emotional woman) let their egos get in the way of a potentially viable product.
Failure. Your board is a failure. You are a failure. MNKD will be failure once the FDA issues another CRL and/or rejection due to a lack of bioequivalence and clinical utility.
Many good points here, but these benefits must be balanced against the fact that the elderly have decreased lung function and increased COPD and other cardiovascular risk factors.
It's of no small consequence why Mannkind has been trying for some time to conduct Affrezza studies on COPD patients.