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Post by mssciguy on Aug 4, 2015 17:08:56 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! The arab countries and Israel seemed very interested (and they can afford it). The US is pretty needle-friendly, with those receptacles for sharps in many restrooms, but in the long run, I can't see how those insulin pens will ever compete in the prandial space. I read a paper from the UAE today (thanks to another proboards member ;-) and it was the very first time in 30 years as a scientist that I saw Goldman Sachs mentioned..... are they really qualified to be meddling here? Of course there is big bucks in gloom and doom.
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Post by mannmade on Aug 4, 2015 17:11:24 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! Let's ask David Hasselhoff...
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Post by prosper on Aug 4, 2015 18:02:16 GMT -5
Since I have a substantial number of Aug calls that are drowning(actually down to a tiny stream of soda water bubbles) under water that would be meaningful Any factual verification would be greatfully appreciated.
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Post by kc on Aug 4, 2015 18:16:14 GMT -5
Harry,
You might be onto something as Sanofi seems to have a very quiet way of working with the various approval agencies and they do it methodically. Look how fast / swiftly they have moved with Toujeo in the USA, Japan and the European countries. You can bet that they have a very sizable and experienced team who know how to deal with regulators. MannKind was perhaps challenged in that area as it took human resource capital to work thru the approval process and MannKind was always financially strapped to spend the big bucks as the process was drawn out.
20 July 2015 EMA/CHMP/483193/2015 Procedure Management and Committees Support Division Committee for medicinal products for human use (CHMP) Draft agenda for the meeting on 20-23 July 2015
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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Post by 1 percenter on Aug 4, 2015 18:26:01 GMT -5
DOn't believe this has anything to do with Afrezza otherwise it would actually mention "afrezza" as all the other drugs listed are named.
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Post by tigiron on Aug 4, 2015 18:26:26 GMT -5
1. Is the applicant SNY or MNKD? 2. extension of clock stop ... is this simply a meandering way of saying extension?
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Post by xoxoxoxo on Aug 4, 2015 21:49:26 GMT -5
The EMA doesn't want companies to prematurely submit drugs for approval. As a result they have strict timelines on companies to prevent them from submitting things early. So an extension of a clock stop actually seems concerning to me, because the company hasn't been able to answer the EMA's questions. However, maybe they are trying to submit additional data that would result in a better label in europe, that could be extremely positive and worth a delay. A clock stop is: TIME ALLOWED FOR APPLICANTS TO RESPOND TO QUESTIONS AND ISSUES RAISED DURING THE ASSESSMENT OF NEW MARKETING AUTHORISATION APPLICATIONS IN THE CENTRALISED PROCEDURE Following the release of the LoOIs at day 180, applicants should respond in writing within 1-month. Only very limited new data derived from new studies would be acceptable at this point of the procedure as assessment time beyond day 180 is extremely limited. In exceptional circumstances, a 1-month extension in submission of the written responses may be granted only upon provision of appropriate scientific justifications to be reviewed and agreed upon by the CHMP. The request for an extension of the timeframe should be submitted as soon as possible and addressed to the CHMP Chairman. In case the LoOIs is to be addressed partly or completely as part of an oral explanation, this will normally be scheduled one month after the submission of the written responses Source: www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500005056.pdfNote: there's no proof these entries are related to Afrezza
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Post by chyaboi on Aug 4, 2015 23:44:02 GMT -5
DOn't believe this has anything to do with Afrezza otherwise it would actually mention "afrezza" as all the other drugs listed are named. After reviewing the documents harry posted, there seems to be a few drugs not listed by any particular drug names. (i.e. page 15 enoxaprin sodium). By the way, are there other drugs on the market that are referred to "insulin human?"
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Post by beardawg on Aug 5, 2015 6:07:59 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... At least one of the documents actually has the one we are looking at listed as a biosimilar
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Post by findingomega on Aug 5, 2015 10:15:49 GMT -5
If I am reading this correctly, Mannkind/Sanofi asked for an extension to answer outstanding questions. Is this correct If so, why is this a positive? Thanks.
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Post by dannykatz on Aug 5, 2015 10:37:08 GMT -5
The third link mentions a different company as the applicant "Novo Nordisk" on page 80
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Post by hankscorpio7 on Aug 5, 2015 11:05:37 GMT -5
The third link mentions a different company as the applicant "Novo Nordisk" on page 80 That has different number. 03858 or 14.1.11 is one in question I think. I would be surprised if this is Afrezza.
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Post by mnholdem on Aug 5, 2015 14:06:38 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... At least one of the documents actually has the one we are looking at listed as a biosimilar Oddly enough, a new entry for an API that has been proven effective and has been marketed for a long, long time can, in the EMA's eyes, be considered a "biosimilar". In the case of Afrezza, the API is human insulin. The first generation of man-made insulin call "human insulin" were created in the 1980's. A topic found at the EMA website, biosimilars are usually candidates for fast-tracking of authorization. However, in Afrezza's case, the new pulmonary-delivery system likely warrants a full review, but the API used in Afrezza is definitely not new.
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Post by jay1ajay1a on Aug 5, 2015 14:12:13 GMT -5
What is Human Insulin
Human insulin was approved for use in 1982
Human insulin is the name which describes synthetic insulin which is laboratory grown to mimic the insulin in humans.
Human insulin was developed through the 1960s and 1970s and approved for pharmaceutical use in 1982.
Before human insulin was developed animal insulin, usually a purified form of porcine (pork) insulin, was used.
How is human insulin produced?
Human insulin is laboratory created by growing insulin proteins within E-coli bacteria (Escherichia coli).
What types of human insulin are available?
Human insulin is available in two forms, a short acting (regular) form and an intermediate acting (NPH) form.
NPH (Neutral Protamine Hagedorn) insulin, also known as isophane insulin, is a suspension meaning that the insulin vial should be rolled or repeatedly turned upside down to ensure the solution is uniformly cloudy.
Some examples of human insulin: Regular (short acting): Humulin S, Actrapid, Insuman Rapid NPH (intermediate acting): Humulin I, Insuman basal, Insulatard Premixed human insulins: Humulin M2, M3 and M5, Insuman Comb 15, 25 and 50
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