d********2
发帖数: 1042 | 1
Adam就是个跳梁小丑
MNKD这次通过的几率还是挺大的
前一次没过有若干个原因：（1）shkreli私下里做了小动作 （2）FDA的官员私下里购
买了MNKD的股票, 这个不能作为FDA否决的理由，但有负面影响，可也从另一个方面反
映出AFREZZA事实上前景很好 （3）FDA上次并没有因为AFREZZA的疗效和安全因素否据
他的批准，原文里只是要求MNKD证明新的准备上市的吸入器跟申报时试验用的吸入器等
效，并勉强要求补充新的对比数据。
需要考虑的正面因素:
(1)MNKD的老板就是做胰岛素泵发家的，对吸入式胰岛素供药有着深刻地了解，对它的
可行性安全性必然知根知底，否则也不会把自己的身家也投进来
(2)Adam的论据其实是站不住脚的，他只是质疑AFREZZA的疗效，事实上AFREZZA并不是
要取代传统注射药物，而是提供了一个方便的选择。MNKD也没有宣称AFREZZA完全胜过
传统的注射剂，其卖点在于快速而且方便。试想一下如果你出门在外，甚至在餐厅就餐
，需要胰岛素的时候，孰优孰劣一目了然
(3)还是那句话，FDA并没有因为AFREZZA的疗效而拒绝它，只是要求补充数据，这次... 阅读全帖 |
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f**********g
发帖数: 2252 | 4 来自主题: _Stockcafeteria版 - MNKD MannKind Says FDA Review Of Afrezza To Take Four More Weeks
0 minutes ago - Dow Jones News
Related Companies
Symbol Last %Chg
MNKD 7.97 0.00%
As of 4:00 PM ET 12/27/10
DOW JONES NEWSWIRES
MannKind Corp. (MNKD) said the U.S. Food and Drug Administration's review of
its new drug application for its inhaled-insulin product for diabetics will
require four additional weeks.
The biopharmaceutical company, which has no products on the market currently
, had been expecting FDA approval of Afrezza by Wed... 阅读全帖 |
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f**********g
发帖数: 2252 | 5 MannKind Says FDA Review Of Afrezza To Take Four More Weeks
0 minutes ago - Dow Jones News
Related Companies
Symbol Last %Chg
MNKD 7.97 0.00%
As of 4:00 PM ET 12/27/10
DOW JONES NEWSWIRES
MannKind Corp. (MNKD) said the U.S. Food and Drug Administration's review of
its new drug application for its inhaled-insulin product for diabetics will
require four additional weeks.
The biopharmaceutical company, which has no products on the market currently
, had been expecting FDA approval of Afrezza by Wed... 阅读全帖 |
|
f**********g
发帖数: 2252 | 6 MannKind Says FDA Review Of Afrezza To Take Four More Weeks
0 minutes ago - Dow Jones News
Related Companies
Symbol Last %Chg
MNKD 7.97 0.00%
As of 4:00 PM ET 12/27/10
DOW JONES NEWSWIRES
MannKind Corp. (MNKD) said the U.S. Food and Drug Administration's review of
its new drug application for its inhaled-insulin product for diabetics will
require four additional weeks.
The biopharmaceutical company, which has no products on the market currently
, had been expecting FDA approval of Afrezza by Wed... 阅读全帖 |
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O**I
发帖数: 776 | 7 【 以下文字转载自 pennystock 俱乐部 】
发信人: OSCI (TX), 信区: pennystock
标 题: FDA Drug Approvals in 2011
发信站: BBS 未名空间站 (Sat Jan 8 17:29:50 2011, 美东)
http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
... 阅读全帖 |
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D*******0
发帖数: 2523 | 8 我真觉得它有可能是下一个REGN, 呵呵。
他目前唯一的一个药：Afrezza.
吸入式的超快速胰岛素。
去年FDA批了，今年初开卖。
这个药不光比一般注射式的方便太多，更重要的是用过的人好评强烈，药效也强很多(
虽然没有officially肯定yet)。
要知道糖尿病人数以几十million记，市场之广大。
有各种理由成为世上卖得最好的药。
主要问题是医生接受太慢，因为they won't change if nothing is broken yet.
这个药的药效officially"不比别的差", 但说它officially比别的强需要时间put on
the label.
现在卖点还是在方便(一般type 1 糖尿病人几十年如一日，每天注射好几针, 想想他们
的皮肤)， 和病人强烈要求。
退一万步讲，只需要25万人长期用这个药，就可以support $10股价。
最后，这个吸入的办法还可以不太难的推广到很多别的药上(好比止疼药，有药效快很
多，和不上瘾的巨大好处)。这种前景也许更广阔，但必须在Afrezza被证明成功的前提
下.
如果一旦成功，很多大公司will be in ... 阅读全帖 |
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w**a
发帖数: 3510 | 9 Top Picks Update
MannKind (MNKD 1.32)
From Nate’s Notes
Though shares of MannKind (MNKD) have continued to struggle following a
reverse split that was carried out back in March, the company's lead
product, Afrezza (an inhaled form of insulin for both Type-1 and Type-2
diabetics) is continuing to win high praises and gain converts among the
small number of patients who have actually heard about it so far.
Up until this point, the company has done virtually no advertising of the
product, but this ... 阅读全帖 |
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O**I
发帖数: 776 | 11 http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
Orexigen Therapeutics Inc.| OREX
DOWN
Dendreon Corporation| DNDN
InterMune Inc.| ITMN
For easy reference, I've organized this regulatory ... 阅读全帖 |
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O**I
发帖数: 776 | 12 http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
Orexigen Therapeutics Inc.| OREX
DOWN
Dendreon Corporation| DNDN
InterMune Inc.| ITMN
For easy reference, I've organized this regulatory ... 阅读全帖 |
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w*******0
发帖数: 13 | 13 BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
For easy reference, I've organized this regulatory calendar in chronological
order based on the drug approval decision date. I've also included
information on pending FDA advisory panels. At the end of the calendar is a
list of companies with potential regulatory milestones in 2011 based on
expected but not yet completed drug approval filings.
In all, this calendar ... 阅读全帖 |
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w*******0
发帖数: 13 | 14 BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
For easy reference, I've organized this regulatory calendar in chronological
order based on the drug approval decision date. I've also included
information on pending FDA advisory panels. At the end of the calendar is a
list of companies with potential regulatory milestones in 2011 based on
expected but not yet completed drug approval filings.
In all, this calendar ... 阅读全帖 |
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h*******o
发帖数: 4884 | 16 I don't think there is any oral insulin on the market. A bunch of them are
under clinical trial
You might wanna try inhalation.
Afrezza (an fast acting inhale insulin drug) from Mannkind is expecting an
FDA approval in the coming months. |
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x***y
发帖数: 830 | 17 赌的来看FDA panel讨论的live blog吧，就像在赌场看开盘一样刺激。
www.thestreet.com/story/12567709/1/mankind-afrezza-fda-panel-live-blog.html |
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n****8
发帖数: 294 | 18
adam feuerstein:
I'll say it now....
MNKD and its supporters were right about Afrezza approval.
I was wrong.
Still waiting for T2 vote but it will also be positive. |
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h*******o
发帖数: 4884 | 19 I don't think there is any oral insulin on the market. A bunch of them are
under clinical trial
You might wanna try inhalation.
Afrezza (an fast acting inhale insulin drug) from Mannkind is expecting an
FDA approval in the coming months. |
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n****e
发帖数: 1677 | 20 MNKD有抄头,Afrezza的三期临床和partner deal都是抄作点,而且都可能在上半年发生. |
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b*****h
发帖数: 783 | 22 100m convertible note 的 convert rate大概是6.8$/share, 当时借给boa的8M
short 用的股票在45天后要被归还， 这些note holder可以从市场买股票来归还，或者
用手里的note来变换。
mnkd这一阵眼花缭乱的融资已经把股价打压下来很多。他的吸入式insulin 产品
AFREZZA 面对的市场大，股价在稳定后会有上升空间。 |
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f*******0
发帖数: 221 | 23 MNKD -- the alleged Afrezza data fraud occurred at clinical trials sites in
Russia and Bulgaria, according to the lawsuit. |
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D******9
发帖数: 2665 | 24 how many chance will AFREZZA have to get FDA nod? |
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t******g
发帖数: 462 | 25 Thanks.
ALXA 如何? 马上12号有个FDA panel, 好象不是很positive
http://seekingalpha.com/article/311279-5-healthcare-companies-w
A few days later Alexza's (ALXA) Adasuve is slated to face the FDA's Advisory Committee. Adasuve was rejected in October 2010 (under the name AZ-004) citing adverse pulmonary reactions as well as a required human factors study to validate the product can be used successfully. Alexza states these issues are resolved, but the Advisory Committee has stated it will focus on pulmonary safe... 阅读全帖 |
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K********g
发帖数: 9389 | 26 这个垃圾不碰
Advisory Committee. Adasuve was rejected in October 2010 (under the name AZ-
004) citing adverse pulmonary reactions as well as a required human factors
study to validate the product can be used successfully. Alexza states these
issues are resolved, but the Advisory Committee has stated it will focus on
pulmonary safety. Adasuve may be in the same boat as Mannkind's (MNKD)
Afrezza. Both are novel inhalation powders that have po: ssible pulmonary
reactions. Therefore we will likely see th... 阅读全帖 |
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b*****h
发帖数: 783 | 27 alxa 是小公司，没长期投资价值。
不过12号的panel 对短期炒作影响很大， 上下50％的幅度吧。
基本就像这个评论写的。
FDA 对它的安全性有疑问。
我感觉fda 态度还可以，而且这个是phase 1 trial 中出现的问题，placebo control
中也有，感觉不会太严重。
不过panel 结论不好预测，risk 挺大的。
Advisory Committee. Adasuve was rejected in October 2010 (under the name AZ-
004) citing adverse pulmonary reactions as well as a required human factors
study to validate the product can be used successfully. Alexza states these
issues are resolved, but the Advisory Committee has stated it will focus on
pulmonary safety. Ada... 阅读全帖 |
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