|
Post by agedhippie on Dec 14, 2018 5:45:02 GMT -5
I am a little lost. This is from July 11. Did something new happen? Nothing new has happened, but judging from the way the last sentence ended I suspect it should have read - The next step is approval for Afrezza.
|
|
|
Post by patten1962 on Dec 14, 2018 6:37:45 GMT -5
I am a little lost. This is from July 11. Did something new happen? Nothing new has happened, but judging from the way the last sentence ended I suspect it should have read - The next step is approval for Afrezza. Thank you for the feed back!
|
|
|
Post by veritasfiliatemporis on Dec 14, 2018 7:42:23 GMT -5
I believe Mannkind is no more supporting a (how can I say this) marketing segmentation. ( if you think my english is too bad, you are right)
|
|
|
Post by mnkdfann on Dec 14, 2018 8:34:42 GMT -5
|
|
|
Post by agedhippie on Dec 15, 2018 7:21:41 GMT -5
It was news to most of us, I suspect. In October of last year, Anvisa had rejected Biomm's application for Glargilin: Assuming Biomm gets approval for Afrezza, how is Biomm going to split its resources? That's easy. They will assign their resources to whatever makes them the most money and keeps their insulin plant working cost effectively. They have sunk an awful lot of money into building that plant and they need to show a return unless they want the shareholders to stake them out on an ant hill.
|
|
|
Post by mnholdem on Dec 15, 2018 17:40:14 GMT -5
I thought the ANVISA rejection was related to Biomm’s application for manufacturing gargline. This is not a problem with Afrezza since MannKind will be supplying it to Biomm and ANVISA has both inspected the Danbury plant and has approved the inhalation device.
|
|
|
Post by sayhey24 on Dec 15, 2018 18:51:32 GMT -5
It was news to most of us, I suspect. In October of last year, Anvisa had rejected Biomm's application for Glargilin: Assuming Biomm gets approval for Afrezza, how is Biomm going to split its resources? That's easy. They will assign their resources to whatever makes them the most money and keeps their insulin plant working cost effectively. They have sunk an awful lot of money into building that plant and they need to show a return unless they want the shareholders to stake them out on an ant hill. It seems to me they face the same issue Brandicourt faced. Assuming 90% plus of the glargalin sales will be to T2s, if they sell afrezza to the T2s today they will never need the glargalin tomorrow. Brandicourt decided to drop the afrezza.
Long term this will prove to be the wrong answer and Sanofi continues to see decreasing Lantus sales. They should have put the effort into doing the studies and changing the T2 SOC. If they had they would be growing the diabetes division now and afrezza would be starting to dominate.
|
|
|
Post by mnholdem on Dec 16, 2018 14:54:15 GMT -5
|
|
|
Post by mnkdfann on Dec 16, 2018 15:56:09 GMT -5
On December 14, Brazil's ANVISA announced that registration of 17 models of glymeters devices used to measure blood sugar levels had their registration canceled because they did not reach the desired level of performance. "Anvisa canceled the registrations of 17 models of glymeters. The decision was taken to withdraw from the market only products that do not meet the international standard of performance described in ISO 15197: 2013." I'm not sure, but offhand (from the list the article contains, see below) it appears that many of those same devices are used in the U.S. Does the U.S. not require that those devices meet the same ISO standards? Freestyle Lite Strips - Blood Glucose Test Abbott 80146501707 Contour TS (Blood Glucose Meter) Bayer 80384380012 Contour TS (Blood Glucose Test Strip) Bayer 80384380008 Easy Thrueread (Glucose Monitoring System) HDI 80095080018 Family of Glucose Strips: Easy True Read / Sidekick - Glucose Reagent Strips HDI 80095080020 Injex Glucose Meter Sens N Injex 10160610062 Injex Sens N - Blood Glucose Test Strips Injex 10160610057 Onetouch Ultra Mini System Johnson & Jonhson 80145901138 Blood Glucose Metering System Onetouch Select Simple Johnson & Johnson 80145901388 Onetouch Ultra Reagent Strips Johnson & Johnson 80145900869 Onetouch Select Reagent Strips Johnson & Johnson 80145901261 True Read Glucose Test Strips Nipro 80788620009 Easy Glucose Meter Trueread Nipro 80788620006 Accu-Check Glucose Monitor (Photometer) Roche 81414021673 Accutrend Glucose Roche 10287410219 Accutrend Plus Roche 10287410740 Tensortip Glucose Meter Family VR Medical 80102511569
|
|
|
Post by mnholdem on Dec 16, 2018 19:45:37 GMT -5
Brazil has a public healthcare system so I'm thinking that the government's standards may be different than they are within the USA, perhaps to limit the number of products within their system.
|
|
|
Post by goyocafe on Dec 16, 2018 20:12:44 GMT -5
Brazil has a public healthcare system so I'm thinking that the government's standards may be different than they are within the USA, perhaps to limit the number of products within their system. I hope they got the new label info and STAT data before rendering their decision.
|
|
|
Post by mnholdem on Dec 16, 2018 23:28:31 GMT -5
Of course they would have. Probably more.
|
|
|
Post by goyocafe on Dec 17, 2018 0:40:24 GMT -5
Of course they would have. Probably more. I mention it only because the improved PK/PD profile, now that it is on the label, and the STAT data, provide compelling reasons to approve. My point being, shouldn’t we be even more surprised because of the newer information since FDA approval if ANVISA denies it.
|
|
|
Post by babaoriley on Dec 17, 2018 1:49:48 GMT -5
Are we sure inhaled products work the same in the southern hemisphere; consider the Coriolis effect...
|
|
|
Post by mike0475 on Dec 18, 2018 16:51:05 GMT -5
Days are limited to hear about Brazil. Seriously why is it alway like pulling teeth?
8 days left?
|
|