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Post by ashiwi on Apr 8, 2014 22:16:02 GMT -5
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Post by hansmolo on Apr 19, 2014 11:36:02 GMT -5
Has anyone heard whether or not they're still planning on presenting the data at the ADA conference?
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Post by nadathing on Apr 20, 2014 12:08:37 GMT -5
I can't imagine why they wouldn't present all the data. I suspect that Al is planning to show the world his crown jewel. If anything, the FDA will have a lot of explaining to do if they reject Afrezza on July 15th. The Adcomm overwhelming voted 41-1 and 13-1 that Afrezza is safe and effective. Afrezza met the endpoints established by them and MNKD. After the ADA the FDA will have to answer to the world why they rejected Afrezza if that comes to pass.
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Post by brentie on Apr 20, 2014 14:32:28 GMT -5
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Post by ashiwi on Apr 21, 2014 9:50:02 GMT -5
Great memories. Nice to see such positivity and the stock up $2 to $9/share on the video.
Looking forward to this year's ADA and more of the same.
Seems like Deja Vu all over again.
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Post by hansmolo on Apr 21, 2014 12:33:45 GMT -5
Hey everybody. I just spoke with Roberta at Mannkind, who I believe is Matt's assistant. She let me know that the PDUFA delay in no way alters the plans to present the data at the ADA meeting. She didn't know which day they'll be presenting though.
She also reiterated that the delay was not a surprise, and that the FDA does not have to wait until July 15th to make a decision. Very nice lady!
PS Awesome vid Brentie. I hadn't seen that one yet.
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Post by thekindaguyiyam on Apr 21, 2014 15:23:16 GMT -5
if it's the same companies it's been a hell of a long conversation. |
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Post by brentie on Apr 21, 2014 15:38:31 GMT -5
if it's the same companies it's been a hell of a long conversation. Ain't that the truth!!! It's time to get something done so they can hit the ground running come July 15th. |
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Post by harshal1981 on Apr 21, 2014 16:15:28 GMT -5
So finally why they are not on the schedule to present in that case?
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Post by hansmolo on Apr 21, 2014 16:25:32 GMT -5
Harshal, if you click on the 2nd link that Spiro posted, you'll see that Mannkind has a booth.
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Post by ashiwi on Apr 21, 2014 19:42:44 GMT -5
Yes they have a booth, but will they be presenting data from their most recent phase 3 trials. It's the biggest diabetes stage in the world. MNKD needs to be the center stage. I was under the impression that there was data to be presented at the meeting. I just couldn't find MNKD/Afrezza in any listed presentation.
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Post by babaoriley on Apr 21, 2014 21:59:35 GMT -5
Ashiwi, sometimes it just seems that the stock gods are hell bent to keep us poor!!
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Post by oncostat on Apr 21, 2014 23:28:03 GMT -5
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Post by babaoriley on Apr 22, 2014 1:13:22 GMT -5
Oncostat? What are you doing here? Are you not, or were you not in Oncy? If so, welcome!!! If not, welcome!!!
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Post by otherottawaguy on Apr 22, 2014 8:07:46 GMT -5
Not 100% sure but thought you were on the EXEL wagon as well?
OOG
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