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Post by kc on Aug 26, 2014 9:27:33 GMT -5
This is a very interesting find on the net from the UK. Glad to see that we are moving along towards approval in the UK. Notice the FDA approval date? this is the first time that I have seen June 14, 2014. Do you think this was a typo? Or did the MannKind folks know this on June 14 and kept it a secret? Makes me wonder about how the Price of the shares changed from 6/14 - 6/27. This is troublesome in my view as perhaps there was price manipulation of share prices during that period that could have been prevented. In any event its good to see that Sanofi is off and running to get UK approval. It seems that perhaps even soon than we anticipate as the comment UK launch Plans: Available only to registered users
seems to indicate that they have filed dates already. www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4631UKMi commentAfrezza® is currently in Phase III development in the UK and US. It is predicted for launch in the UK in 2015. |
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Post by kc on Aug 26, 2014 9:57:32 GMT -5
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Post by dreamboatcruise on Aug 26, 2014 12:02:36 GMT -5
Companies often enroll patients in foreign countries as part of FDA submission. It makes enrollment go quicker and is likely cheaper than doing all the trial in the U.S. I don't think where they are done has much relevance to approval, though perhaps some jurisdictions require a portion of trials to be done local. |
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Post by kc on Aug 26, 2014 12:50:06 GMT -5
You are correct as I drilled down your message, and found that trials have ocuured in 66 different locations from a 2012 article. It does give me more confidence that Sanofi will be able to win approval in many countries accross the world in a timely basis. diatribe.org/issues/41/trial-watch trial will last 24-weeks, and it will recruit participants at 66 centers in the US, Russia, the Ukraine, and Brazil |
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Post by pmikeks on Aug 26, 2014 14:24:16 GMT -5
This is one of the things that really frustrate me about Mannkind management. They could be talking about this as well as other factors without "giving up any secrets. Management's PR is more like what you would see in a privately held company not a corporation. I understand "quiet time" not giving up secrets etc but I doubt they would say "Poop" if they had a mouthful. Why couldn't they talk about the above entry efforts in other countries, why couldn't they explained "planned sales by insiders" (many analysts and bloggers didn't get it was planned and we got punished accordingly) and why can't they share many of the positive things the medical field has said about their rapid acting insulin and revolutionary delivery system. I believe the PPS could be 50% higher if they had a good PR firm to guide them instead of a "mums the word" philosophy.
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Post by 4Balance on Aug 26, 2014 16:38:06 GMT -5
When it says "No" re NICE timetable, what does that mean...?? |
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Post by daduke38 on Aug 26, 2014 17:06:04 GMT -5
kc, I didn't catch the date difference this morning. How could they have legally sat on that for 2 weeks? And how are we in Phase III trials in the UK? Did the company ever announce a filing there? I have to agree with a certain poster on the YBM who goes off about every other day about the lack of transparency. Dang, maybe he has a point. Not sure if its my memory or did they even mention Technosphere at the Quarterly CC? And we may be in another quiet period, but we get this Partner announcement with very few details, and pure silence since from both parties. The only news from SNY was about Israel and we find out about the UK from somebody doing detective work? I feel better, Had my little rant for the day  |
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Post by dreamboatcruise on Aug 26, 2014 17:58:17 GMT -5
kc, I didn't catch the date difference this morning. How could they have legally sat on that for 2 weeks? And how are we in Phase III trials in the UK? Did the company ever announce a filing there? I have to agree with a certain poster on the YBM who goes off about every other day about the lack of transparency. Dang, maybe he has a point. Not sure if its my memory or did they even mention Technosphere at the Quarterly CC? And we may be in another quiet period, but we get this Partner announcement with very few details, and pure silence since from both parties. The only news from SNY was about Israel and we find out about the UK from somebody doing detective work? I feel better, Had my little rant for the day They have stated that the deal specifics will be attached to Sept quarter SEC filings. They obviously could have chosen to release these early. You better get some chill pills if lack of info before early Nov is going to drive you crazy, because the companies have given every indication that they are in stealth mode until then. |
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Post by rockstarrick on Aug 26, 2014 18:42:03 GMT -5
All I can say is good job on the find, it's members like this that keep us all centered. Things are moving as planned, they must have a reason for the silence, but they aren't just sitting in the office with their feet propped up. I think when they do decide to speak, they will have a lot more to talk about then most think. I got nothing but time. RSR
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Post by biotec on Aug 26, 2014 19:08:32 GMT -5
This for phase 3 trials. I hope we passed that timeline already LOL.Wow phase 3 was in many countries around the world.Why make this a big deal ?
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Post by daduke38 on Aug 26, 2014 20:29:39 GMT -5
kc, I didn't catch the date difference this morning. How could they have legally sat on that for 2 weeks? And how are we in Phase III trials in the UK? Did the company ever announce a filing there? I have to agree with a certain poster on the YBM who goes off about every other day about the lack of transparency. Dang, maybe he has a point. Not sure if its my memory or did they even mention Technosphere at the Quarterly CC? And we may be in another quiet period, but we get this Partner announcement with very few details, and pure silence since from both parties. The only news from SNY was about Israel and we find out about the UK from somebody doing detective work? I feel better, Had my little rant for the day They have stated that the deal specifics will be attached to Sept quarter SEC filings. They obviously could have chosen to release these early. You better get some chill pills if lack of info before early Nov is going to drive you crazy, because the companies have given every indication that they are in stealth mode until then. No, I just needed a rant! Iam ok now, LOL |
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Post by bobw on Aug 27, 2014 15:57:10 GMT -5
I believe that we have completed phase 3 in Europe when we completed the 171 and 175 trials. Those trials were always meant to serve as the basis for submission in Europe.
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