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Post by straightly on Oct 22, 2017 3:46:54 GMT -5
This time around, it might be "goodies are in the details" It is almost too good to be true that Chineses seemed to open the door to allow selling drugs WHILE collecting data.
"第六章 附 则
第二十三条 对于用于危重疾病、罕见病、儿科用药且缺乏有效治疗手段的药品注册申请，经评估其境外临床试验数据属于“部分接受”情形的，可采用有条件接受临床试验数据方式，在药品上市后收集进一步的有效性和安全性数据用于评价
Chapter 6, addendum
Item 23, of medications for severe diseases, rare diseases, pediatric specialty diseases where effective treatments are lacking, registration applications will be evaluated based on their overseas' trial data. Should such data qualifies for "partial acceptance", they can be accepted conditionally and the collection and assessment of effecacy and safty data can ve deferred to after the medication has been marketed."
It is noted else where that diabetes IS one of the diseases considered by Chinese gov considered to be severe.
Hoping MNKD will find a way to at least start the registration application before the big pharmas covered China and claim effective treatments are no longer lacking.
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Post by straightly on Oct 22, 2017 3:55:26 GMT -5
This time around, it might be "goodies are in the details" It is almost too good to be true that Chineses seemed to open the door to allow selling drugs WHILE collecting data. "第六章 附 则 第二十三条 对于用于危重疾病、罕见病、儿科用药且缺乏有效治疗手段的药品注册申请，经评估其境外临床试验数据属于“部分接受”情形的，可采用有条件接受临床试验数据方式，在药品上市后收集进一步的有效性和安全性数据用于评价 Chapter 6, addendum Item 23, of medications for severe diseases, rare diseases, pediatric specialty diseases where effective treatments are lacking, registration applications will be evaluated based on their overseas' trial data. Should such data qualifies for "partial acceptance", they can be accepted conditionally and the collection and assessment of effecacy and safty data can ve deferred to after the medication has been marketed." It is noted else where that diabetes IS one of the diseases considered by Chinese gov considered to be severe. Hoping MNKD will find a way to at least start the registration application before the big pharmas covered China and claim effective treatments are no longer lacking. |
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Post by barnstormer on Oct 22, 2017 7:42:25 GMT -5
Isn't is possible that Amphaster has already done some of the ground work for approval in China since the have a right to the distribution in China?
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Post by straightly on Oct 22, 2017 11:13:20 GMT -5
Isn't is possible that Amphaster has already done some of the ground work for approval in China since the have a right to the distribution in China? Possible. But if Afrezza application is officially submitted, it will be a big shot in the arm. Just want Afrezza to catch the wave. |
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Post by agedhippie on Oct 22, 2017 20:48:35 GMT -5
Isn't is possible that Amphaster has already done some of the ground work for approval in China since the have a right to the distribution in China? It doesn't have the right to distribution, it has first refusal. Mannkind cannot commence filing for approval in China without giving Amphastar 90 days written warning at which point Amphastar has 30 days to decide if it wants to proceed and if so they have 60 days to negotiate terms. If no agreement is struck at the end of that 90 days Mannkind can approach other companies but must offer Amphastar the right to match any terms agreed with another company. |
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Post by straightly on Oct 22, 2017 22:52:06 GMT -5
Isn't is possible that Amphaster has already done some of the ground work for approval in China since the have a right to the distribution in China? It doesn't have the right to distribution, it has first refusal. Mannkind cannot commence filing for approval in China without giving Amphastar 90 days written warning at which point Amphastar has 30 days to decide if it wants to proceed and if so they have 60 days to negotiate terms. If no agreement is struck at the end of that 90 days Mannkind can approach other companies but must offer Amphastar the right to match any terms agreed with another company. Sounded like we are well tangled. Any source of this info for us to read up? On the application, it seemed that MNKD should immediately start by giving the 90 notice: then 90 day later, either MNKD is free to apply or Amphastar would be applying. The later does not make sense though: Sounded to me MNKD can negotiate a deal with a partner, only to give up the deal to Amphastar, unless it is on terms Amphastart cannot accept. Who would ever do that? And Amphastar can simple occupy the stoll without doing any business? |
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Post by agedhippie on Oct 23, 2017 7:28:49 GMT -5
It doesn't have the right to distribution, it has first refusal. Mannkind cannot commence filing for approval in China without giving Amphastar 90 days written warning at which point Amphastar has 30 days to decide if it wants to proceed and if so they have 60 days to negotiate terms. If no agreement is struck at the end of that 90 days Mannkind can approach other companies but must offer Amphastar the right to match any terms agreed with another company. Sounded like we are well tangled. Any source of this info for us to read up? On the application, it seemed that MNKD should immediately start by giving the 90 notice: then 90 day later, either MNKD is free to apply or Amphastar would be applying. The later does not make sense though: Sounded to me MNKD can negotiate a deal with a partner, only to give up the deal to Amphastar, unless it is on terms Amphastart cannot accept. Who would ever do that? And Amphastar can simple occupy the stoll without doing any business? If you want to read up on it then the best (only?) thing to do is the contract itself. In particular read section 6.5 which is where the rights are set out. You can start the clock running, you can even hit the 90 day mark, you can negotiate a whole deal with a partner, but Amphastar still has the right to step in at the end and take the deal if they want to. This was part of the price of escaping the original Amphastar deal. |
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Post by barnstormer on Oct 23, 2017 8:15:22 GMT -5
So essentially Amphaster has the rights based on first right of refusal. It would seem they would be willing to get the ball rolling sooner rather than later now that Afrezza has an improved label. Waiting is just leaving money on the table.
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Post by mnholdem on Oct 23, 2017 9:08:03 GMT -5
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Post by bradleysbest on Oct 23, 2017 10:45:14 GMT -5
After FDA approval and the initial partnership with that shitty company, Japan was listed as a country Afrezza would target & achieve milestone payments for.... Is Japan still a designated target for Afrezza?
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Post by peppy on Oct 24, 2017 8:02:21 GMT -5
After FDA approval and the initial partnership with that shitty company, Japan was listed as a country Afrezza would target & achieve milestone payments for.... Is Japan still a designated target for Afrezza? yes (Insulin Human)
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