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Post by harryx1 on Aug 4, 2015 10:36:29 GMT -5
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Post by rozale on Aug 4, 2015 12:28:42 GMT -5
That would be good news, if the reports are referencing Afrezza!
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Post by dstevenson on Aug 4, 2015 12:46:00 GMT -5
Hm but would sanofi or mnkd need to disclose that they have filed?
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Post by mnholdem on Aug 4, 2015 12:49:09 GMT -5
If this is Afrezza, this indicates that the application review has reached Day 180 of an EMA process that has a maximum allowable review period of 210 days.
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3.4. Update on on-going initial applications for Centralised procedure 3.4.1. insulin human - EMEA/H/C/003858 treatment of diabetes Scope: Request for an extension of clock stop Action: For adoption Day 180 list of outstanding issues adopted 25.06.2015. List of Questions adopted on 23.10.2014. Letter from the applicant dated 8 July 2015 requesting extension of clock-stop to respond to Day 180 list of outstanding issues
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Unless the applicant's extension request adds to the maximum allowable 210 days (which is then followed by a final review of 30-45 days), then Sanofi is only a few months away from announcing that Afrezza has been authorized for centralized marketing in Europe - IF THIS APPLICATION IS FOR AFREZZA.
That would be stunning news.
Is there any way to flesh this out?
There is a list of minutes (pdf) posted from both the Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Medicinal Products for Human Use (CHMP)
www.ema.europa.eu/ema/index.jsp?curl=search.jsp&q=003858&btnG=Search&mid=
How would I find the sponsor/applicant for EMEA case file 003858?
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Post by bradleysbest on Aug 4, 2015 13:44:40 GMT -5
Could we be 15 days away from some great news? August 19 would be day 210 if my math is correct....
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Post by kc on Aug 4, 2015 14:30:24 GMT -5
OTHER COMPANY DEVELOPMENTS ? VALENCIA, Calif., Aug. 4, 2015 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) will release its 2015 second quarter financial results on Monday, August 10, 2015 and its management will host a conference call to discuss the second quarter financial results and other Company developments at 9:00 AM (Eastern Time) on August 10, 2015.
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Post by liane on Aug 4, 2015 14:40:59 GMT -5
kc, That's boilerplate - they say that every time.
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Post by esstan2001 on Aug 4, 2015 14:43:22 GMT -5
OTHER COMPANY DEVELOPMENTS ? VALENCIA, Calif., Aug. 4, 2015 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) will release its 2015 second quarter financial results on Monday, August 10, 2015 and its management will host a conference call to discuss the second quarter financial results and other Company developments at 9:00 AM (Eastern Time) on August 10, 2015. Ratchet your expectation down to 'we re-tiled the men's bathroom on the 2nd floor'
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Post by esstan2001 on Aug 4, 2015 14:44:15 GMT -5
this would be awesome if it tuns out to be the case.
Once again Harry, great sleuthing.
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Post by hankscorpio7 on Aug 4, 2015 14:53:52 GMT -5
Depends on duration of clock stop. Opinion 30 days from restart, decision up to 60 days from there. I was under impression SNY would wait for new trial results to improve label for EU. Would they stop clock for 3-6months? I vote no. Is this the reason for jan. 16 $5 call volume?
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Post by james on Aug 4, 2015 14:56:15 GMT -5
To be clear, I don't know, but I don't have any expectations here. The documents suggest to me that this is for a biosimilar (generic) human insulin. I am really expecting an announcement of some sort when the EMA filing is submitted as this would be a material event. There also may be additional trial data available before that occurs.
Edit: hankscorpio has scooped me on the trial data suggestion...
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Post by charlespk on Aug 4, 2015 14:57:36 GMT -5
Harry , thanks ,you are still # 1 at finding out the latest , hopefully it's for Afrezza. Don't have time to look at the links right now , because i am trying to get some work done . This morning I posted a list of potential things to expect , so this would fall under Item # 5., see below CC for August 10,2015 was announced this morning , so I made a list of what we might or not hear. 1) Sales of Afrezza- since Sanofi already announced sales for the quarter last week , this should be a non - event, as I doubt they will release figures for just July . 2) Milestone payment due to validation of the 12 unit cartridge - I seem to recall that this would trigger a milestone payment, but cannot recall if this is speculation or accurate information . 3) If milestone payment is announced, when will be it on the books ? 4) Announcement of 2nd TS partnership , this would be probably the best surprise , but in my opinion, they are not ready for this yet , would love to hear from other board members regarding this item . 5) Announcement of approval in another country , this will happen at some point, but for Afrezza , it may be Sanofi and not Mannkind who breaks the news on it. 6) Convertible notes - it would be great to hear something better than what has already been said , but as others mentioned , its a day before . 7) Buyout - although most of us dream that this would be announced , it's way too early for any buyout , this will not occurr until sales are significantly higher . 8 ) Announcement of % of insurance plans that have upgraded the tier status for Afrezza, this could be the best news for shareholders of Mannkind ( Again a Sanofi announcement ?) 9) SNY has taken a 5 % stake in Mannkind . Would love to hear what everyone else is thinking regarding the above , and especially if other items can be added to this list . 9 As always , GL Read more: mnkd.proboards.com/thread/3157/conference-call-on-august-expect#ixzz3hsTspufW
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Post by dreamboatcruise on Aug 4, 2015 15:07:11 GMT -5
OTHER COMPANY DEVELOPMENTS ? VALENCIA, Calif., Aug. 4, 2015 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) will release its 2015 second quarter financial results on Monday, August 10, 2015 and its management will host a conference call to discuss the second quarter financial results and other Company developments at 9:00 AM (Eastern Time) on August 10, 2015. Ratchet your expectation down to 'we re-tiled the men's bathroom on the 2nd floor' Or as with lines 2-3... "The re-tiling of the men's bathroom should be complete any day now. I don't track that, but it may already be in operation."
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Post by BlueCat on Aug 4, 2015 15:16:14 GMT -5
Ratchet your expectation down to 'we re-tiled the men's bathroom on the 2nd floor' Or as with lines 2-3... "The re-tiling of the men's bathroom should be complete any day now. I don't track that, but it may already be in operation." Call SNY. Just don't say we told you that.
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Post by roseylv on Aug 4, 2015 16:45:17 GMT -5
Has anyone seen the documentary, "Sugar Man"...
Wouldn't it be ironic just like in the documentary a man (Rodriguez) creates music here in the US but unbeknownst to him, his music bombs in the US but makes it to the top of the charts in South Africa. Could Afrezza be the next Sugar Man in a multitude of countries other then USA?
Just a bit bored here leading up to earnings :-)
Good luck to all of us Longs!
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