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Post by longstocking on Aug 19, 2015 19:05:53 GMT -5
Have you seen this new update today on the UK NHS site?
Aug 15: Results of PIII trial, published in Diabetes care, found that in patient with TIIDM and HbA1c levels over or equal to 7.5% but less than 10% despite metformin alone or two or more oral antidiabetics, add-on prandial Afrezza reduced HbA1c by -0.4% (95% CI -0.575 to -0.23%) compared to placebo (p<0.0001) [32].
19/08/2015 13:56:56
www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4631 Key word being "found", as in past tense. Is it done? |
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Post by longstocking on Aug 19, 2015 19:15:13 GMT -5
Have you seen this new update today on the UK NHS site?
Aug 15: Results of PIII trial, published in Diabetes care, found that in patient with TIIDM and HbA1c levels over or equal to 7.5% but less than 10% despite metformin alone or two or more oral antidiabetics, add-on prandial Afrezza reduced HbA1c by -0.4% (95% CI -0.575 to -0.23%) compared to placebo (p<0.0001) [32].
19/08/2015 13:56:56
www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4631 Key word being "found", as in past tense. Is it done? What is the typical length of time needed for Phase III trials? July 15 date also says "found". If each of these entries are just status updates then they might still give us an idea of how long the Phase III trials have been ongoing. |
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Post by Chris-C on Aug 19, 2015 19:30:30 GMT -5
That study is complete. It could be interpreted as another indication that the decision by the European Medicines Agency is getting closer. The mystery about launch plans for the EU remain shrouded. I wonder if anyone on the board has a pharmacist friend practicing in the UK who could access this? Even if so, I'm guessing the data is considered confidential or they would no be protecting it from outsiders.  Chris C |
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Post by longstocking on Aug 19, 2015 19:37:36 GMT -5
That study is complete. It could be interpreted as another indication that the decision by the European Medicines Agency is getting closer. The mystery about launch plans for the EU remain shrouded. I wonder if anyone on the board has a pharmacist friend practicing in the UK who could access this? Even if so, I'm guessing the data is considered confidential or they would no be protecting it from outsiders. Chris C Still good news though. Have to keep trusting management. Hope they give us some info soon. |
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Post by cyn on Aug 19, 2015 19:45:03 GMT -5
kc, I'm really impressed on how you accessed this recent find. That's OK, I don't need to know. I must be having a really bad day in navigating these overseas health regulatory websites.
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Post by kc on Aug 19, 2015 19:51:54 GMT -5
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Post by longstocking on Aug 19, 2015 20:43:20 GMT -5
No kidding. Can't believe you beat Harry on this. |
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Post by harryx1 on Aug 20, 2015 7:43:32 GMT -5
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Post by cjc04 on Aug 20, 2015 9:44:20 GMT -5
Great thread here,,, thanks to all for the work...
I'm continuing to "have faith" in mgmt, but it's starting to feel like I've got my fingers crossed and eyes closed with my over weight position in MNKD, vs. the feeling of confidence in my DD and belief in the product.
I do have a question / idea,,,,,, IF we are that close to EMA approval, I wonder if this is what Matt is waiting for, hence the 1 month extension on the debt converts.
I recall Matt saying, within the past few months, when referring to a question on the Aug debt "no reason the sp shouldn't be over 6.80 by then" ..... I instantly had that feeling that is circulating again now, that he knows something!!! Well that didn't work out....
Was/is he waiting for EMA approval?
Would this trigger a major milestone payment, giving reason for his confidence on this issue?
I understand it's all speculation, just trying to connect any dots possible given all the secrecy, and find something other than "hope" to get thru this as my largest investment continues to deteriorate.
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Post by longstocking on Aug 20, 2015 13:16:20 GMT -5
Great thread here,,, thanks to all for the work... I'm continuing to "have faith" in mgmt, but it's starting to feel like I've got my fingers crossed and eyes closed with my over weight position in MNKD, vs. the feeling of confidence in my DD and belief in the product. I do have a question / idea,,,,,, IF we are that close to EMA approval, I wonder if this is what Matt is waiting for, hence the 1 month extension on the debt converts. I recall Matt saying, within the past few months, when referring to a question on the Aug debt "no reason the sp shouldn't be over 6.80 by then" ..... I instantly had that feeling that is circulating again now, that he knows something!!! Well that didn't work out.... Was/is he waiting for EMA approval? Would this trigger a major milestone payment, giving reason for his confidence on this issue? I understand it's all speculation, just trying to connect any dots possible given all the secrecy, and find something other than "hope" to get thru this as my largest investment continues to deteriorate. I agree with your thoughts on EMA approval and extension of debt. |
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Post by bradleysbest on Aug 20, 2015 15:56:30 GMT -5
MNKD is waiting for something...... no doubt about it! Just hope it is of the good news variety!
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Post by notamnkdmillionaire on Aug 20, 2015 16:26:11 GMT -5
MNKD is waiting for something...... no doubt about it! Just hope it is of the good news variety! Let's just hope they are not waiting for Godot.  |
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