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Post by rockstarrick on Aug 16, 2015 12:21:56 GMT -5
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Post by bradleysbest on Aug 16, 2015 12:23:35 GMT -5
Good find! We can only hope it is true.
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Post by rockstarrick on Aug 16, 2015 12:26:57 GMT -5
It is the first listing in blue box #4. FYI
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Post by notamnkdmillionaire on Aug 16, 2015 13:30:22 GMT -5
I also hope this (human insulin) is aka AFREZZA. The first paragraph give some details as why human insulin is what is used.
Key sentence:
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Post by jbe on Aug 16, 2015 14:16:28 GMT -5
I hope this Afrezza, but could be pretty much any insulin....
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Post by rockstarrick on Aug 16, 2015 14:23:49 GMT -5
Yes I agree, when no company or drug name is listed, the only thing one can do is share and maybe someone can dig a little deeper for better clarification.
My question is, what other is up for EMA approval in August 2015. We did just conclude p3 clinical trials didn't we. I thought I read that the clinical trials were complete.
Can anyone confirm this.
Thanks
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Post by daduke38 on Aug 16, 2015 14:28:37 GMT -5
RSR,
It says on the 1st page that "new" applications are in bold letters. The one you are refering to isn't, so it has been submitted prior to August is what I deduct. The big question, Is it Afrezza?
Wouldn't an application be material enough to have to be made public?
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Post by Chris-C on Aug 16, 2015 14:33:40 GMT -5
I hope this Afrezza, but could be pretty much any insulin.... I'd say the odds are very good it is Afrezza. My reasons for asserting this: 1) It has been pending for several months and the timing would be consistent with the timing of the partnership agreement with SNY. Harryx1 was the first to find this, as I recall, and posted it in another thread about EMA, I believe going back we established that the initial appearance was in January or February. 2) SNY has made it clear that they are seeking a global market for Afrezza 3. Afrezza is: Insulin human. (see labeling). EMA does not use proprietary names in its list, so it would be inappropriate and inconsistent to list it as Afrezza. IMPORTANT SAFETY INFORMATION FOR AFREZZA® (INSULIN HUMAN) INHALATION POWDER (From the Mannkind Website). Regards, Chris C |
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Post by bradleysbest on Aug 16, 2015 14:35:19 GMT -5
If it is Afrezza , approval is not far off!
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Post by rockstarrick on Aug 16, 2015 15:12:51 GMT -5
This list was compiled August 10th 2015, the day of our CC
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Post by rockstarrick on Aug 16, 2015 15:14:54 GMT -5
RSR, It says on the 1st page that "new" applications are in bold letters. The one you are refering to isn't, so it has been submitted prior to August is what I deduct. The big question, Is it Afrezza? Wouldn't an application be material enough to have to be made public? The information was compiled on August 10 2015. dont know Daduke, just found and shared. |
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Post by Chris-C on Aug 16, 2015 16:29:36 GMT -5
RSR, It says on the 1st page that "new" applications are in bold letters. The one you are refering to isn't, so it has been submitted prior to August is what I deduct. The big question, Is it Afrezza? Wouldn't an application be material enough to have to be made public? The information was compiled on August 10 2015. dont know Daduke, just found and shared. I was mistaken. The "Insulin Human" application on the list was first entered in July 2014. See link here . Mannkind announced its agreement with Sanofi in September, 2014. Mannkind announced FDA approval in June, 2014. So, it is anyone's guess if Mannkind had an application ready to submit to the EMA (that would be a good tactical move) and submitted it very soon after US FDA approval. On the other hand, Mannkind was clearly in discussions with SNY at that point, so it is anyone's guess whether the submission entry is for Afrezza and done by MNKD or in coordination with SNY, since initial application was made 13 months ago as of this month and shortly before the partnership announcement was made. Incidentally, Toujeo has already been approved by the EMA, FWIW. You can read the Toujeo details here. It was approved by the EMA in April, 2015. It would be great if the insulin human application under review is Afrezza, and if so, one could expect a recommendation very soon, one would think. Too bad they don't have a PDUFA date equivalent. Regards Chris C |
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Post by rockstarrick on Aug 16, 2015 17:01:27 GMT -5
This is from CNA
Struggles…Not For Long
MannKind Corporation (NASDAQ: MNKD)
After producing better than expected earnings on Monday, MannKind has had an incredible time in the market this week. However, solid earnings wasn’t the only factor that played a role in the company’s gains. MannKind also brought on a new, highly qualified and highly respected chief medical officer by the name of Dr. Urbanski and announced that they are close to regulatory approval for Afrezza in Europe. Nonetheless, it seems as though the bears are short selling the stock; causing a bit of manipulation at the expense of real investors. Nonetheless, I expect that the bulls will take control of MNKD again relatively soon. Currently (1:43), MNKD is trading at $4.17 per share after a loss of 3.25%. Nonetheless, today’s declines represent a strong opportunity to get in on future gains at a discount.
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Post by bradleysbest on Aug 16, 2015 17:34:33 GMT -5
When was it "announced"?
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Post by luckyjoe on Aug 16, 2015 17:37:37 GMT -5
Sorry guys. According to the heading this is a biosimilar insulin. Not Afrezza.
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