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Post by liane on Mar 28, 2014 12:51:37 GMT -5
They could vote to recommend for T2 and not T1. It's still up to the FDA to approve. They could label it indicated for T2 only if they choose. The thing I have not said bluntly enough is that once the drug is out there - no matter the label says - docs can and will prescribe it off label. You do run into problems getting it past insurance companies sometimes. But the docs, especially the specialists, can often argue the need to cover it.
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Post by thsloppy on Mar 28, 2014 12:52:24 GMT -5
This morning scared me straight as well. I think this therapy will be amazing once on the open market and MD's and patients really understand how to maximize the benefits. I just don't like the uncertainly raised about the T1 data. I especially don't like the last line on page 182. We lose in 2 of 3 areas. While I think the Adcom may take the same perspective as our physician on this board and take into consideration the big picture (I would), I'm not so sure the FDA will. Yes the results met endpoints but is the data use to reach that endpoint acceptable? I have sold 20K shares and kept 15K. Still long. Too much risk for me at my old position. If it does make it through, I'll likely buy all back in as I think the long term future would be off the charts.
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Post by liane on Mar 28, 2014 12:55:07 GMT -5
They could vote to recommend for T2 and not T1. It's still up to the FDA to approve. They could label it indicated for T2 only if they choose. Liane or anyone else, do you have any knowledge of whether or not FDA has been wrong in interpreting data given to it by companies to the point that the company has to actually correct the FDA on their findings? The FDA could be wrong??? Seriously, I don't know the answer to your question with certainty. This is why Adcom is good for us. If the FDA is leaning in the wrong direction, it gives the sponsor company a chance to try and correct the interpretation.
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Post by biotec on Mar 28, 2014 12:57:09 GMT -5
People need to calm down, I don't see all the red flags people are talking about. These docs mean nothing, What does is the vote from 4 to 5 next tuesday the 1rst. They MNKD/FDA/committee has all day to talk about these points. And remember Al said MNKD is going to bring in some perfessionals that will help sort these things out.
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Post by thsloppy on Mar 28, 2014 13:01:05 GMT -5
Biotec...hope you are right. It is all about risk / reward tolerance per individual. A few things rubbed me wrong and I adjusted my position accordingly.
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Post by biotec on Mar 28, 2014 13:04:48 GMT -5
sorry meant to say the docs do mean something but the Adcom is what counts
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Post by alcc on Mar 28, 2014 13:11:21 GMT -5
My take: we knew about the numerical inferiority re A1c v. RAA in 171. The claim of statistical non-inferiority squeaked by by a hair, which we know is likely to draw scrutiny. That has always been my concern. So this is not exactly a surprise.
As I posted after reading the Exubera adcom minutes, I felt the adcom will actually be helpful. Going by the briefing doc, if it were up to the FDA, they might well reject, at least re T1. They appear to have a narrow focus on A1c. The FDA rep said pretty much the same thing in the Exubera adcom, that A1c is the "only" accepted metric for measuring efficacy. However, in that adcom, adcom members immediately countered that A1c is just one measure and not very useful re the actual, real-life effects on and concerns of the patient. For whatever reason, perhaps conservatism, the FDA appears to continue to put imo undue weight on A1c. Very frustrating. Thus, I say again, I think (ok, hope) adcom will come to the rescue and inject a wider perspective on how to treat T1 and why metrics such as FPG and hypo events are just as, if not more, important. I think there will be a split vote for T1. Hoping for 7-2 (as per Exubera), certainly not less than 6-3. How the FDA takes that vote input is another matter. In the case of Exubera, T2 was an afterthought by comparison and sailed through 9-0. I expect similar outcome here. But T1 is the key. As an insulin, Afrezza will be judged by T1.
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Post by mannmade on Mar 28, 2014 13:19:11 GMT -5
My two cents with Two things:
1.) Let's not forget these studies were designed in very close and on-going communication with the FDA
2.) There is a mathematician on the panel and so should be able to speak to statistics in a non-biased way, meaning as I recall we were told that the T1 results were not statistically relevant between .05 and .04
3.) another add: the hba1c issue I thought was part of the severe hypo discussions... meaning with a new first in class drug this measurement may no longer be relevant if (when) Afrezza is approved... Al has said this quite a few times...
4.) Also with regard to missing data, I may be a bit confused here, but i believe their was some mention of this a while back and Mankind put up a FAQ section on their site to answer this and other perceived issues.
5.) Lastly, wasn't there a statement that they needed some unpublished info to present at ADA conference in June?
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Post by babaoriley on Mar 28, 2014 13:21:53 GMT -5
Hello, I've been following this board since last fall.Today I sold 95% of my MNKD stock, I dont like the feeling anymore, to much risk. As soon as I read the FDA docs it was time to sell. Never ever fall in love with a single stock, Al might pull it off but its a huge up hill battle all the way.For anyone with MNKD as more the 20% of your portfolio Dont blame the FDA when you loss it all. I know this wont make me many friends but I could care less. Good luck, Im out. Longmann, understand completely, and good luck with your five remaining shares. Oh, almost forgot, thanks for finally coming on the board today after all these months to cheer us all up!
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Post by babaoriley on Mar 28, 2014 13:25:42 GMT -5
People need to calm down, I don't see all the red flags people are talking about. These docs mean nothing, What does is the vote from 4 to 5 next tuesday the 1rst. They MNKD/FDA/committee has all day to talk about these points. And remember Al said MNKD is going to bring in some perfessionals that will help sort these things out. But our professionals may have to check their guns at the front desk.
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buck
Newbie
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Post by buck on Mar 28, 2014 13:26:46 GMT -5
Regarding "missing data" mentioned in the FDA conclusion, isn't this really based on the fact that MannKind only conducted one Type 1 trial. Thus that is the only data available to the FDA for Type 1's. IMO MannKind did not withold any data. Rather, they supplied all the data they had for Type 1 trials. Please correct me if I'm wrong here.
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Post by harshal1981 on Mar 28, 2014 14:15:39 GMT -5
Missing Data = The END point data not available due to drop out of patients during the trial due to various reasons. For calculating weather the trial met endpoints or not, those patients are excluded since they didn't complete the trial. However, FDA statisticians perform sensitivity analysis using four widely accepted methods. Most conservative being assuming that all the patients that dropped out would have performed worst in the trial pool had they completed the trail. And then they recalculate the endpoint performance. The data that they 'assume' for such sesitivity analysis is called missing data in their language. NO ONE HIDE ANY THING... NO ONE WITHHELD ANY THING.
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buck
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Post by buck on Mar 28, 2014 15:35:49 GMT -5
Thanks for the clarification on "missing data."
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Post by goyocafe on Mar 28, 2014 15:52:15 GMT -5
People need to calm down, I don't see all the red flags people are talking about. These docs mean nothing, What does is the vote from 4 to 5 next tuesday the 1rst. They MNKD/FDA/committee has all day to talk about these points. And remember Al said MNKD is going to bring in some perfessionals that will help sort these things out. Question: What did Deerfield see that lead them to lend so much more money to MNKD and take a larger equity position to boot?
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Post by liane on Mar 28, 2014 18:39:30 GMT -5
Looking at the premarket now as well. 11% to the upside. What time do you figure they trigger their sell off. I am guessing we might see red in the afternoon sometime, once the Fudsters have had a chance to spew their slanted reads on the briefing notes. I will now be waiting until Monday to make the call as to whether to add more it seems. Give them a chance to spin it downwards from whereever it end today. OOG You just couldn't leave well enough alone. It's all your fault! Just kidding - it's been a long day. I'll be much happier once we get past the 1st and then the 15th. Where's Spiro - haven't heard from him all day. Must have broke out the ouzo early. Can't say I blame him.
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