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Post by harshal1981 on Mar 28, 2014 11:06:59 GMT -5
So here is my conclusion.
I do not think we will have any issue related to Comparability of Gen2 vs. Medtone. Spirometry results are more than accepted as per the reviewers comments.
Major and in fact very challenging question they ask is:
For T1 Study:
1) They titrated afrezza way more often than control (insulin aspart) arm. They challenge that if they would have adequately titrated control arm, the study would have failed. 2) Fact that afrezza arm received more basal insulin and still performed less numerically, questions the role that basal insulin in playing in reducing HbA1c. All though they acknowledge that afrezza is playing different role here and less hypos indicate that it is doing its job and basal did its job. They acknowledge the challenge. 3) The big sore point is sensitivity analysis due to drop outs which they consider Missing data. There are four ways of performing the missing data. most conservative is that for every drop out patient, you add 0.4 highest possible contribution to upper control (i.e. assuming that they performed worst in the gout had they stayed in the trial thorugh out). If they do sensitivity using this method, trial would be considered not meeting primary endpoint. However, there are three other methods they consider several reasonable factors to exclude some patient dropout from including in sensitivity analysis. And for all those three methods, trial still meets primary end point.
It seems, panel will be divided on T1. For T2,
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Post by liane on Mar 28, 2014 11:08:00 GMT -5
mannmade,
In the end, I think we get approved for T1 and T2. A study does not reflect the real world; you design it the best you can, but during the study, there are rigid parameters that cannot be changed while it is ongoing. There will always be things that could have been done better. In these studies, the primary endpoints were met. But for the 171 (T1) study - just barely. And in fact, insulin aspart was better (using these study parameters) at reducing A1c. Does that mean, TI should not be approved - NO. But it does get at the heart of the matter - is A1c the best way to measure the effectiveness of TI. And how much of a role does TI play vs basal. I think in the real world, what will need to happen is to increase the basal or go to a twice a day dosing. Then let TI handle the prandial spikes. Bottom line - safe and "effective" (in its unique way). But a lot more dose tweaking is needed. That should not keep it off the market. There are so many advantages to having treatment options. Convenience, lack of needles, and improved compliance will weigh heavily.
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Post by noonen on Mar 28, 2014 11:18:01 GMT -5
Hi all, thanks for the comments and the continued quality of the board. still lurking (often) and hope next couple weeks go alright for us all. Does anybody have experience with previous adcomms/drugs where the dosage was different on the label than in the trial? I'm assuming (hoping) that since this issue (page 19 of fda pdf) hasn't really been raised as one of the main issues by people here that it's not a a huge deal? I really hope not.
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Post by noonen on Mar 28, 2014 11:21:48 GMT -5
Hi all, thanks for the comments and the continued quality of the board. still lurking (often) and hope next couple weeks go alright for us all. Does anybody have experience with previous adcomms/drugs where the dosage was different on the label than in the trial? I'm assuming (hoping) that since this issue (page 19 of fda pdf) hasn't really been raised as one of the main issues by people here that it's not a a huge deal? I really hope not. nevermind, answered in post directly above with regards to tweaking of dosage safety being most important. thanks Liane.
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Post by mdcenter61 on Mar 28, 2014 11:40:29 GMT -5
Personally, after reading page 182 for about the fourth time as well as the questions, I frankly don't see how they could NOT approve for T2. Type 1 could get hairy but I would think a possible scenario is Type 2 approval and further tests for Type 1. Doesn't that at least open the door for the primary market and gets commercialization in gear?
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Post by dreggy on Mar 28, 2014 12:14:26 GMT -5
I don't think they can approve for t2's and not for t1's. They either approve Afrezza, or they don't. The t1 vs t2 debate will simply be reflected in the label. There will still be Dr.'s who will prescribe off-label.
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Post by liane on Mar 28, 2014 12:21:01 GMT -5
I don't think they can approve for t2's and not for t1's. They either approve Afrezza, or they don't. The t1 vs t2 debate will simply be reflected in the label. There will still be Dr.'s who will prescribe off-label.Bingo! Initially, the endos will dip their toes, but eventually the FPs will see how good this is and do the same. Admittedly, there is a subset that hold off prescribing any new drug for at least a year. To each their own. Word will get out, and the market will drive it.
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Post by longmann on Mar 28, 2014 12:28:54 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.
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Post by mrhaigs on Mar 28, 2014 12:31:04 GMT -5
Sorry guys but these docs are scaring the poop out of me. Do all docs have THIS negative of a tone? I've been on a plane all morning so I haven't been able to get into this much as I wished I could have.
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Post by mdcenter61 on Mar 28, 2014 12:33:57 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.
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Post by BD on Mar 28, 2014 12:35:20 GMT -5
I'm quivering in my boots...NOT LOL
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Post by mdcenter61 on Mar 28, 2014 12:35:49 GMT -5
I don't think they can approve for t2's and not for t1's. They either approve Afrezza, or they don't. The t1 vs t2 debate will simply be reflected in the label. There will still be Dr.'s who will prescribe off-label.Bingo! Initially, the endos will dip their toes, but eventually the FPs will see how good this is and do the same. Admittedly, there is a subset that hold off prescribing any new drug for at least a year. To each their own. Word will get out, and the market will drive it.
Just so I understand this, there are separate votes for Type 1 and Type 2; so if it is a split down vote for Type 1 and a very positive vote for Type 2 Afrezza won't be approved?
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Post by liane on Mar 28, 2014 12:42:29 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.
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Post by notamnkdmillionaire on Mar 28, 2014 12:44:45 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. Well thanks for your one disingenuous post after all this time lurking!
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Post by notamnkdmillionaire on Mar 28, 2014 12:46:24 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?
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