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Post by harshal1981 on Apr 1, 2014 8:27:46 GMT -5
I am here at the AdCom .. Will share imp updates here ...
1) Mnkd successfully established that low Hypos are not becos Afrezza arm had lower reduction in a1c ... Even after adjusting numbers for less a1c , it showed 26% less hypos ... A satayistically significant less hypo
Prior to that another mnkd consultant MD presented how important the convenience is as patients tend to delay going on to insulin for up to 5 yrs .. She also put forebears case for how important it is to control hypos
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Post by harshal1981 on Apr 1, 2014 8:40:18 GMT -5
2) mnkd presented lung function data comparing reduction over time between non diabetics , diabetics on OAD or injection insulin and TI insulin ... To prove that lung function reduces due to age in go healthy persons , more due to diabetes irrespective of TI or Injection .. Of course TI reduces slightly more compared to other two .. Showing that fev 1 reduction can't be seen in absolute ... Comparative reduction in fev1 for TI is really next negligent
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Post by harshal1981 on Apr 1, 2014 9:58:01 GMT -5
Dr Lisa Yanoff is certainly not supportive it seems ... Her argument is that patients enrolled verse healthy so doctors should have titrated comparator arm higher ... She is almost claiming that comparator arm was not titrated intentionally so as not to get better result with comparator arm
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Post by harshal1981 on Apr 1, 2014 10:00:01 GMT -5
She is harping on missing data ... Her claim is that 171 should be assumed failed if u consider all drop outs to be worst performs
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Post by harshal1981 on Apr 1, 2014 11:51:02 GMT -5
Just before lunch during q and a...
A panel member who is bio statistician raise very good question to fda as to why 0.4 CI limit for this product when it is not same as any other insulin ... FDA said its sponsors responsibility to support why 0.4 and not 0.3 or why not 0.5
She didn't seem to buy FDA s argument
Ann endocrinologist on panel also ask fda to explain dr Yanoff as to why she is playing down Benefit of less hypos in Afrezza ... Her reply was since a1c reduction was less a can't really rely on less hypo as advantage ... More over hypo data is patient reported so there is now way to quality control ... ... Which again to ne is not really logical .. It's a trade off of a1c vs hypo ... U can't really ignore less hypo becos less reduction a1c not sure if panel member bought that justification
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Post by BD on Apr 1, 2014 14:02:47 GMT -5
14:57 EDT MNKD theflyonthewall.com: Advisory meeting 'looking very good' for MannKind, Feuerstein says
An FDA advisory committee meeting regarding MannKind's Afrezza is "looking very good" for the company, according to Adam Feuerstein of TheStreet.com. Feuerstein stated in a live blog of the meeting that he has "not heard a single comment from panel which would suggest a no vote."
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Post by bigboy on Apr 1, 2014 14:16:30 GMT -5
Sitting at the AdCom meeting. Would be very surprised at a negative outcome. Sailed through T1 discussion. t2 up now
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Post by BD on Apr 1, 2014 15:26:12 GMT -5
First voting result: 13-1 in favor for Type 1.
Heh heh.
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Post by harshal1981 on Apr 1, 2014 15:34:16 GMT -5
1 guy who didn't vote left early. I so hate that guy. Why would you be on the panel if you had early flight to catch. Well the verdict is really clear so not that it matters much but still...
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Post by BD on Apr 1, 2014 15:43:40 GMT -5
Type II: 14 yes, 0 no. Not too shabby  |
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Post by cannon5974 on Apr 1, 2014 15:50:01 GMT -5
Congrats Longs!! I am fired up!!!  |
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Post by mnkdwillwin on Apr 1, 2014 15:51:50 GMT -5
What a super afternoon
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Post by esstan2001 on Apr 1, 2014 15:52:58 GMT -5
congrats and thanks to all!!!
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Deleted
Deleted Member
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Post by Deleted on Apr 1, 2014 15:55:10 GMT -5
Congratulations to everyone!!!
It is time to celebrate tonight. Tomorrow I will get back to reality.
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Post by StevieRay on Apr 1, 2014 15:55:30 GMT -5
I nominate Spiro to buy everyone the first and last rounds! And I'll buy every other drink in between!
I'm so very pleased and hope the FDA will listen to what was said to them today and approve Afrezza on time! April 15, 2014!
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