t******g
发帖数: 462 | 1 Just for case study
Alexza Wins Panel’s Backing for Inhaled Antipsychotic Drug
Alexza Pharmaceuticals Inc. (ALXA) narrowly won a U.S. panel’s backing to
sell an inhaled antipsychotic drug that may put some patients at risk for
respiratory failure.
The Food and Drug Administration should approve a single daily dose of
Adasuve for schizophrenia and bipolar mania with a risk mitigation plan
proposed by the agency, outside advisers to the FDA said today in a 9-8 vote
in Adelphi, Maryland. The FDA is... 阅读全帖 |
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t******g
发帖数: 462 | 2 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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d******8
发帖数: 1972 | 3 Alexza Pharmaceuticals: Forward Looking Approval Catalyst In Play
http://seekingalpha.com/article/313829-alexza-pharmaceuticals-f
Last week, shares of Alexza lost 47% of their value after an internal FDA
Review found that their inhaled antipsychotic might pose fatal lung risks.
The report, which was released on Wednesday was enough to send speculators
packing. (See our previous report) Shares of the company surged after the
advisory committee voted 9/8/1 (yes/no/abstain) on the issue.
"We view t... 阅读全帖 |
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y*****l
发帖数: 5997 | 4 22 Hot Drugs Facing FDA Approval in 2012
By Adam Feuerstein 11/29/11 - 08:55 AM EST
BOSTON (TheStreet) -- Here's your first look at the biotech and
pharmaceutical companies with pending FDA drug approval decisions in 2012.
The calendar on the following pages captures nearly two-dozen U.S.
regulatory events -- FDA drug approvals and advisory panels -- expected
between December 2011 and July 2012. As every savvy biotech investor and
trader knows, the volatility in biotech and drug stocks ramps sig... 阅读全帖 |
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K********g
发帖数: 9389 | 5 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 | 6 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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g****e
发帖数: 1426 | 7 ALXA still has huge upside in near term:
1. Today's partnership news with TEVA:
TEVA will pay Alexza $40 million upfront and it could make another $195
million in milestone payments based on completion of post-approval studies
and sales targets. Alexza will also receive royalties on sales of the drug,
and Teva will lend Alexza up to $25 million to support Adasuve activities
over the next five years.
2. Highly undervalued, market cap is only $83.78m with today's share closing
price $5.31. Total c... 阅读全帖 |
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