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全部话题 - 话题: nda
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s**u
发帖数: 137
1
来自主题: Pharmaceutical版 - 新剂型报NDA
前景,难度都和具体的产品有关,所以没有一个笼统的答案。
如果你是在评估一家公司的话,那么不但要了解这个产品,看它是否有足够的positive
differentiation,还要看公司有没有相当的财力。这种NDA叫做505(b)(2),通常需要一
定程度的Efficacy Study,因此研发费用比generics贵很多。此外,这样的产品需要fi
eld sales force to promote,这更是传统意义上的generic公司所不具备的。
L***J
发帖数: 10
2
FDA刚批准了老药ibuprofen注射剂型:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm165971.htm
这种改剂型的药的申报归到哪一类?NDA?ANDA?
r***o
发帖数: 162
3
NDA for iv ibuprofen.
t*******o
发帖数: 1464
g******0
发帖数: 1165
5
☆─────────────────────────────────────☆
7月份
http://www.mitbbs.com/clubarticle_t2/pennystock/31456677.html
☆─────────────────────────────────────☆
8月份
http://www.mitbbs.com/clubarticle_t2/pennystock/31456701.html
☆─────────────────────────────────────☆
9月份
http://www.mitbbs.com/clubarticle_t2/pennystock/31456711.html
☆─────────────────────────────────────☆
10月份
http://www.mitbbs.com/clubarticle_t2/pennystock/31456723.html
☆─────────────────────────────────────☆
11,12月份
http://www.mitbbs.com/cluba... 阅读全帖
y*****l
发帖数: 5997
6
不清楚是不是sell on news,我拿不住,早上卖掉了。
NDA也不是什么大事,万里长征第一步。
b*****h
发帖数: 783
7
NDA 是预料中的事,没有任何悬念,接下来能stimulate是如果能找到partner,
否则,股价慢慢回落可能性比较大。
b**********k
发帖数: 1262
8
在yahoo 讨论版 上面看到的
1) Dec 2010 - NDA gets filed.
2) Jan 2010 - Phase 2 results. Neuroendrocrine arm results are fantastic.
3) Feb 2010 - FDA give priority review
4) Mar 2010 - Submits phase 2 for ASCO presentation.
5) Mar 2010 - Europe stategy PR along with EU partner or distributor.
6) May 2010 - Phase 3 full results on NEJM for CM/OM.
7) Jun 2010 - ASCO presentation
8) Jun 2010 - CE Mark approval (markets to 27 countries to Europe)
9) Jun 2010 - FDA approval for CM/OM (US market)
b*****h
发帖数: 3386
9
http://seekingalpha.com/instablog/110813-mike-havrilla/17481-extreme-fda-calendar-trades-21-stocks-under-5
On 7/20/09, Trinity Biotech (NASDAQ:TRIB) ($4.88) announced the submission
of a CLIA application for its TRI-stat point-of-care HbA1c product to the
FDA.TRI-stat is designed to measure HbA1c, also known as glycated hemoglobin
, a measure of a patient's average blood sugar control over the trailing two
to three month period. Utilizing a patented boronate affinity and two-phase
optical system... 阅读全帖
h**********i
发帖数: 183
10
“EnverEnver Karakas”adlı Facebook hesabında kısa süre &#
246;nce paylaşılan bir habere göre, yıllar boyunca Tü
rkiye’de saklanan “Doğu Türkistan İslami Hareketi” terör
örgütü elebaşı Abdulkadir Yapçan 31 Ağustos’ta T
ürk polisi tarafından tutuklandı. Bu hesapta yer alan haberde Yap
çan’ın “Çin’in baskısı” nedeniyle Türkiye’de
yakalandığı iddia edildi.
Yurt dış&... 阅读全帖
j***h
发帖数: 4412
11
【 以下文字转载自 JobHunting 讨论区 】
发信人: Ginobili (潘帕斯雄鹰), 信区: JobHunting
标 题: [合集] 给作者: 报google nyc offer,并分享面经
发信站: BBS 未名空间站 (Sat Mar 19 21:31:54 2011, 美东)
☆─────────────────────────────────────☆
wolver (没有) 于 (Sat Mar 19 15:12:23 2011, 美东) 提到:
同学,
(这是关于你的置顶文章, 本来因该私人信件的,但是给后来者一个警告也好)
First, you should know that you have signed an NDA with Google at the
beginning of the on-site interview and things that were said and discussed
during the interview (particularly the interview questions) were cove... 阅读全帖
G******i
发帖数: 5226
12
☆─────────────────────────────────────☆
wolver (没有) 于 (Sat Mar 19 15:12:23 2011, 美东) 提到:
同学,
(这是关于你的置顶文章, 本来因该私人信件的,但是给后来者一个警告也好)
First, you should know that you have signed an NDA with Google at the
beginning of the on-site interview and things that were said and discussed
during the interview (particularly the interview questions) were covered
under the NDA.
第一,你应该知道你面试的时候签过NDA,所有面试过程中说的都是覆盖的,尤其是这
些面试题目。
Second, you are already doing damages to Google before you even started.
Once those ... 阅读全帖
x******y
发帖数: 6946
13
【 以下文字转载自 JobHunting 讨论区 】
发信人: Ginobili (潘帕斯雄鹰), 信区: JobHunting
标 题: [合集] 给作者: 报google nyc offer,并分享面经
发信站: BBS 未名空间站 (Sat Mar 19 21:31:54 2011, 美东)
☆─────────────────────────────────────☆
wolver (没有) 于 (Sat Mar 19 15:12:23 2011, 美东) 提到:
同学,
(这是关于你的置顶文章, 本来因该私人信件的,但是给后来者一个警告也好)
First, you should know that you have signed an NDA with Google at the
beginning of the on-site interview and things that were said and discussed
during the interview (particularly the interview questions) were cove... 阅读全帖
l**t
发帖数: 6971
14
【 以下文字转载自 JobHunting 讨论区 】
发信人: Ginobili (潘帕斯雄鹰), 信区: JobHunting
标 题: [合集] 给作者: 报google nyc offer,并分享面经
发信站: BBS 未名空间站 (Sat Mar 19 21:31:54 2011, 美东)
☆─────────────────────────────────────☆
wolver (没有) 于 (Sat Mar 19 15:12:23 2011, 美东) 提到:
同学,
(这是关于你的置顶文章, 本来因该私人信件的,但是给后来者一个警告也好)
First, you should know that you have signed an NDA with Google at the
beginning of the on-site interview and things that were said and discussed
during the interview (particularly the interview questions) were cove... 阅读全帖
t*****s
发帖数: 2933
15
【 以下文字转载自 SanFrancisco 讨论区 】
发信人: lopt (好好学习天天向上), 信区: SanFrancisco
标 题: [合集] 给作者: 报google nyc offer,并分享面经 (转载)
发信站: BBS 未名空间站 (Sat Mar 19 23:38:42 2011, 美东)
发信人: Ginobili (潘帕斯雄鹰), 信区: JobHunting
标 题: [合集] 给作者: 报google nyc offer,并分享面经
发信站: BBS 未名空间站 (Sat Mar 19 21:31:54 2011, 美东)
☆─────────────────────────────────────☆
wolver (没有) 于 (Sat Mar 19 15:12:23 2011, 美东) 提到:
同学,
(这是关于你的置顶文章, 本来因该私人信件的,但是给后来者一个警告也好)
First, you should know that you have signed an NDA with Google at the
beginning of... 阅读全帖
T*o
发帖数: 363
16
【 以下文字转载自 JobHunting 讨论区 】
发信人: Ginobili (潘帕斯雄鹰), 信区: JobHunting
标 题: [合集] 给作者: 报google nyc offer,并分享面经
发信站: BBS 未名空间站 (Sat Mar 19 21:31:54 2011, 美东)
☆─────────────────────────────────────☆
wolver (没有) 于 (Sat Mar 19 15:12:23 2011, 美东) 提到:
同学,
(这是关于你的置顶文章, 本来因该私人信件的,但是给后来者一个警告也好)
First, you should know that you have signed an NDA with Google at the
beginning of the on-site interview and things that were said and discussed
during the interview (particularly the interview questions) were cove... 阅读全帖
y*****l
发帖数: 5997
17
来自主题: _pennystock版 - Biotech Calendar: 2011 FDA Drug Approvals
http://www.rttnews.com/CorpInfo/FDACalendar.aspx?Node=B8
Date Company Name Ticker Drug Event Outcome Details
08/20/2011 Regeneron Pharmaceuticals REGN VEGF Trap-Eye (BLA)
FDA decision on VEGF Trap-Eye for neovascular form of age-related macular
degeneration (wet AMD).
-News
08/10/2011 Gilead Sciences Inc. GILD Truvada/TMC278 (refiled NDA)
FDA decision on Truvada/TMC278 for HIV-1 infection in adults
-Drug Status
07/28/2011 Pacira Pharmac... 阅读全帖
W********g
发帖数: 610
18
来自主题: _pennystock版 - FDA五六月
06/29/2012 Astellas Pharma Inc. ALPMY.PK, ALPMF.PK Mirabegron (NDA) FDA
decision on Mirabegron for proposed treatment of overactive bladder



-News
06/28/2012 Bristol-Myers Squibb Co. BMY ELIQUIS (NDA) FDA decision on
ELIQUIS for prevention of stroke and systemic embolism in patients with
atrial fibrillation



06/27/2012 Arena Pharmaceutical Inc. ARNA Lorcaserin (NDA) FDA decision on
Lorcaserin for proposed treatment of obesity



06/21/2012 Repligen Corp RGEN SecreFlo... 阅读全帖
s******t
发帖数: 37
19
【 以下文字转载自 Law 讨论区 】
发信人: snowrbbt (ren), 信区: Law
标 题: Non-disclosure and non-compete agreement
发信站: BBS 未名空间站 (Fri Aug 12 11:06:47 2011, 美东)
I was asked to sign a different NDA from the one I agreed on when I was
hired.
I just started a new job with a small company owned by a Chinese American.I
was asked to sign a NDA and I asked for a NDA from my boss before I
accepted the job offer. Now there is another NDA attached in the employee
manual that HR gave to me on the first day I started my new ... 阅读全帖
s******t
发帖数: 37
20
【 以下文字转载自 Law 讨论区 】
发信人: snowrbbt (ren), 信区: Law
标 题: Non-disclosure and non-compete agreement
发信站: BBS 未名空间站 (Fri Aug 12 11:06:47 2011, 美东)
I was asked to sign a different NDA from the one I agreed on when I was
hired.
I just started a new job with a small company owned by a Chinese American.I
was asked to sign a NDA and I asked for a NDA from my boss before I
accepted the job offer. Now there is another NDA attached in the employee
manual that HR gave to me on the first day I started my new ... 阅读全帖
s******t
发帖数: 37
21
【 以下文字转载自 Law 讨论区 】
发信人: snowrbbt (ren), 信区: Law
标 题: Non-disclosure and non-compete agreement
发信站: BBS 未名空间站 (Fri Aug 12 11:06:47 2011, 美东)
I was asked to sign a different NDA from the one I agreed on when I was
hired.
I just started a new job with a small company owned by a Chinese American.I
was asked to sign a NDA and I asked for a NDA from my boss before I
accepted the job offer. Now there is another NDA attached in the employee
manual that HR gave to me on the first day I started my new ... 阅读全帖
s******t
发帖数: 37
22
I was asked to sign a different NDA from the one I agreed on when I was
hired.
I just started a new job with a small company owned by a Chinese American.I
was asked to sign a NDA and I asked for a NDA from my boss before I
accepted the job offer. Now there is another NDA attached in the employee
manual that HR gave to me on the first day I started my new job and HR asked
me to sign this NDA. This NDA described different terms from the one I
originally agreed on when I accepted my job offer. Mos... 阅读全帖
y*****l
发帖数: 5997
23
来自主题: _pennystock版 - 求药股指南。。
简单说就是和你玩ER一样,根据FDA Calendar,选出有炒作价值的药股,如癌症药等,
做Pre-FDA run,没有把握一般不赌FDA。药股选择看俱乐部的生物专家和花街光头的文
章。他这次预测VVUS和CHTP都会通过panel review,都猜对了。
http://www.rttnews.com/CorpInfo/FDACalendar.aspx?Node=B8
http://www.thestreet.com/author/1352996/AdamFeuerstein/all.html
等老牛补充,你准备包子吧,呵呵。
【 以下文字转载自 Stock 讨论区 】
发信人: KeepBuying (雁过留声), 信区: Stock
标 题: 2011年11月-2012年1月的FDA的NDA医药股
发信站: BBS 未名空间站 (Wed Nov 2 00:25:56 2011, 美东)
既然成为板斧了,那就为股版添点东西。
下面的医药股是2011年11-2012年1月的FDA的NDA待审批的。大家记住,任何药股的NDA
风险都比较大,要学会炒药股,切忌去赌药股的NDA.下面... 阅读全帖
v**********m
发帖数: 5516
24
来自主题: _pennystock版 - dcth怎么看
http://seekingalpha.com/article/894061-delcath-systems-an-exclu
Delcath Systems: An Exclusive Interview With ROTH Capital Senior Analyst
September 28, 2012 | about: DCTH
Disclosure: I am long DCTH. (More...)
Today I have the pleasure of publishing an exclusive interview that took
place this week between me and one of the leading senior analysts for
medical technology, Mr. Matt Dolan of ROTH Capital Partners. Mr. Dolan has
followed the industry for nearly a decade and has been the senior analys... 阅读全帖
y*****l
发帖数: 5997
25
来自主题: _pennystock版 - Biotech Calendar: 2011 FDA Drug Approvals
Date Company Name Ticker Drug Event Outcome Details
04/30/2011 GlaxoSmithKline PLC GSK, GSK.L Lamictal-XR (sNDA) FDA
decision on Lamictal-XR for conversion to monotherapy for treatment of
partial seizures FDA approved Lamictal XR for conversion to monotherapy
for treatment of partial seizures on Apr.25
-Drug Status
-Approved in Other Countries
04/29/2011 Spectrum Pharmaceuticals Inc SPPI Fusilev (sNDA) FDA
action on Fusilev for additional use in c... 阅读全帖
v**********m
发帖数: 5516
26
来自主题: _pennystock版 - DCTH 狂跌
8/10/2012 5:34 AM ET
(RTTNews) - Having transitioned from a development stage company to a
commercial organization with operational activities in April of this year,
Delcath Systems Inc. (DCTH:Quote) is gearing up to play its part of
NDA resubmission in the upcoming binary event.
The company's shares have lost over 40% of their value year-to-date, and
trade near their 52-week low. With the company scheduled to resubmit the New
Drug Application for its proprietary chemosaturation system
in a coup... 阅读全帖
i******d
发帖数: 565
27
呵呵,我是做工程咨询服务的,签过有五十份以上NDA文件。以前还看一看文件的内容,现在基本都不看直接签了。因为本行业的NDA内容基本都是大体相同的。目的就是防止我们泄露他们的设计产品给第三方。而实际上我觉得这种NDA也没有太多的约束力。如果我真要泄露他们的设计,技术或者产品给别人,他们也根本无从查起。相比NDA,更多的是需要行业内的自律。当客户关心这个问题的时候,我通常也只是email里面保证小心保管,绝不泄密。NDA也类似于防君子不防小人。
最好采用公司对公司形式的NDA,个人之间的NDA不好说,最好还是要看人品。如果利益涉及不大的话,一方破坏NDA,另一方都难找到律师愿意接这个小案子来打官司。
d******8
发帖数: 1972
28
来自主题: _pennystock版 - AMRN 今天盘后ER
好像没有什么影响。
http://finance.yahoo.com/news/amarin-reports-first-quarter-2012
BEDMINSTER, N.J., and DUBLIN, Ireland, May 8, 2012 (GLOBE NEWSWIRE) --
Amarin Corporation plc (Nasdaq:AMRN - News), a late-stage biopharmaceutical
company focused on cardiovascular disease, today announced financial results
for the quarter ended March 31, 2012 and provided an update on company
operations.
Amarin noted the following highlights since the quarter ended December 31,
2011:
Received Notice of Allowance for paten... 阅读全帖
g****e
发帖数: 1426
29
来自主题: Stock版 - Biotech -- CPRX
Just read SA article below about CPRX -- the next ANRA:
http://seekingalpha.com/article/843531-3-speculative-biotech-st
Reasons to buy:
1. $6M stock offering just completed, that means someone just bought 4M
shares at $1.5
2. Catalyst event CPP-109 Phase IIb result due on or before 09/30
3. Huge market for CPP-109 the treatment of cocaine and methamphetamine
addiction and sensational impact to world on Drug addiction
4. FDA granted CPRX Fast Track status for CPP-109, that means NDA could be
subm... 阅读全帖
K********g
发帖数: 9389
30
今天看到一个又因为买生拉哭的。
我要说说生拉的炒作点,为何买,何时卖,并且啥时候该割,啥时候不割。希望不会再
有人来哭诉了,亏得都是真金哟,我心里都难受。
首先生拉作为投机,是有炒作机会的。一般来说,炒NDA和Trail数据,其他的Buyout之
类的很难。一般来说,好一点的药都有一定的市场前景,那么庄稼就会借这个价值进行
操作。通常NDA比Trial的时间更加明确。
第二,风险很大,因为一般这些药如果不过,并且这个药是是重要的Pipeline的话,那
么股票通常腰斩。如果过了,就要看药的价值以及公司的基本情况了。有很多NDA过了
照样Sell off,例如BDSI,但是也有好的,例如VNDA,SOMX。一般来说,这个很难界定
。所以一般建议散户不要在NDA过了后买,风险很大。
第三,何时买入呢。通常,一个新药申请给该公司带来一定的炒作机会,但是买入时间
一定要把握,并且要做细致地分析,确定这个药过了,那么股票会大致值多少钱,然后
可以明确买入点是否合适。然后再确定买入时间,一般来说,想做生拉一顶提前埋伏,
至少3个月前,我个人觉得。然后就等待庄稼Pump。
第四,何时卖呢?一般来说,... 阅读全帖
v**********m
发帖数: 5516
31
来自主题: _pennystock版 - DCTH 狂跌
NEW YORK, Aug. 15, 2012 /PRNewswire/ — Delcath Systems, Inc. (NASDAQ:DCTH)
announced today that it has submitted a New Drug Application (NDA) to the U.
S. Food and Drug Administration seeking approval for the Company’s
proprietary chemosaturation system for use with melphalan hydrochloride in
the treatment of patients with unresectable metastatic melanoma in the liver
. The Company included its Generation 2 filter in its NDA submission as a
technical change to the Chemistry, Manufacturing, and C... 阅读全帖
f*******7
发帖数: 943
32
来自主题: JobHunting版 - 亚麻onsite总结,攒人品,求好运
很久之前我就来版上了,但是懒的注册号,也不发面经,所以面试总挂。
自从半年前注册了号,发面经求bless后,总体来说几个公司的面试还算smooth,尽管
有个别面试官会给negative,但是还没有被拒,而是继续给多一次的电面机会。
如果这次拿到offer,我会尽我可能给大家发包子祝福大家。
签了NDA,所以这次在合理范围内进行学术讨论
***关于NDA, 不知道有多少同学仔细读了NDA,有一条是
“) you will notify 亚麻厂 immediately upon discovery of any unauthorized
use or disclosure of Confidenti Information or any other breach of this
agreement”
如果我没理解错的话,如果大家签了NDA && 看到了别人的面经
then 必须立即向亚麻厂报告,否则违反NDA?? 哈哈
面试地距宾馆1 mile, 早上走过去了,新鲜空气会让大脑清醒很多, 但是想说一句
apple map sucks。。。一黑哥们跟我一路走过去的,人家用google ma... 阅读全帖
l****n
发帖数: 6896
33
*** 走廊上的谈话
带着满肚子的狐疑,我随他走到大厅走廊的一个角落,那里有几张折叠椅,Dr.
Cattell 打开了两张,我们坐了下来。我还没开口,他先发话了:
“Thank you again for seeing me, Dr. Chao. I’m sure you’re busy so let me
get right down to business. Have you heard of Gallup Consulting before?”
“Hmm..., I’m afraid I don’t think I have.”
“We are the largest contractor for DOD on psychology-related projects. We
have a staff of over 300 people, half of which have one or more Ph.D.
degrees from prestigious institutions around the world. .....”
他说他们所承接的计划什么样的都有,包括了军方... 阅读全帖
b**u
发帖数: 2761
34
来自主题: Pharmaceutical版 - 国内药剂职位(上海)
JOB DESCRIPTION
Title: Principal Scientist / Manager
Department: Pharmaceutical
Report To: Senior Director
Subordinate: Undetermined
Requirements:
 Education: A science degree is required, preferably in
Pharmaceutics or Chemistry. An advanced degree (Pharm D, Masters, or PhD in
a science related discipline) is strongly preferred.
 Experience: Minimum of 5 years of experience with
pharmaceutical development programs, preferably with NDA product development.... 阅读全帖
y*****l
发帖数: 5997
35
来自主题: _pennystock版 - 明天 ANX是升还是降
好像射天狼也是ANX专家,如果FDA能过的话,潜力巨大。
http://seekingalpha.com/article/267816-adventrx-poised-for-run-
Adventrx Pharmaceuticals (ANX) is a specialty pharma company developing two
novel formulations of anti-cancer drugs that are designed to result in less
side effects in addition to a compound in late-stage clinical development
for the treatment of a blood disorder known as sickle cell anemia.
On 3/10/11, ANX reported its 4Q10 and full-year 2010 financial results,
including:
As of 3/1/11, had 23.7 mill... 阅读全帖
t**u
发帖数: 1572
36
来自主题: _pennystock版 - TSPT完了
http://finance.yahoo.com/news/Transcept-Pharmaceuticals-prnews-
其实这个安眠药会影响第二天开车,
Press Release Source: Transcept Pharmaceuticals, Inc. On Tuesday July 12,
2011, 8:02 pm EDT
POINT RICHMOND, Calif., July 12, 2011 /PRNewswire/ -- Transcept
Pharmaceuticals, Inc. (Nasdaq:TSPT - News) announced today that it expects
to receive a Complete Response Letter from the U.S. Food and Drug
Administration (FDA) regarding the resubmitted New Drug Application (NDA)
for Intermezzo® (zolpidem tartrate sublingua... 阅读全帖
v**********m
发帖数: 5516
37
重要的时间点和market 都能在这篇文章里找到。
================
http://www.investorideas.com/CO/BPAX/news/2011/07151.asp
Mr. Stephen M. Simes, President and CEO of BioSante Pharmaceuticals, Inc. (
NASDAQ: BPAX), Discusses the Potential of Future Partners or Acquisition
Point Roberts, WA, LINCOLNSHIRE, Ill – July 15, 2011 –(Investorideas.com
newswire.com) Investorideas.com, an investor research portal covering
leading sectors including biotech and pharma stocks, features an exclusive Q
&A interview with Mr. Stephen M... 阅读全帖
G******i
发帖数: 5226
38
来自主题: JobHunting版 - [合集] 帮忙分析一下(替朋友问)
☆─────────────────────────────────────☆
laurabear (...) 于 (Sat Jan 7 13:40:32 2012, 美东) 提到:
我有一个朋友最近面了西边两个大公司(CS 方向)。 自我感觉很好, 所有的
technical 问题都回答上来了。 可是都没有offer. 这个朋友很是不解, 其中有一个
在面试结束当天晚上,recruiter发信说过一段时间给他发team project 的信息。 他
当时以为offer 没问题了但是过了两周来了据信。会不会是面试的时候说话太多?让人
觉的aggressive,不能fit in? 或是personality 不合适?有经验的朋友帮忙分析一
下。毕竟还是要找出自己的问题, 才能搞定以后的面试。谢了先。
☆─────────────────────────────────────☆
StevenLow (CrossLayer) 于 (Sat Jan 7 14:00:16 2012, 美东) 提到:
overqualify.

☆────────────────────... 阅读全帖
M****o
发帖数: 13571
39
个人与个人之间签NDA的话,要写清楚个人的legal name and address。如果还要更小
心的话,也许可以加上SSN, DL#并get the agreement notarized?
如果你做的东西不受出口管制,就不用"EXPORT CONTROL LAWS" clauses.
有什么条文是因人/情况而异需要特别注意但容易忽视的吗?
- 这个就看你要签这个NDA的目的啦。如果牵扯到payment的话,要写清楚payment
terms,啥算是项目完成了,如何付款,等等。
另外最关键的就是对于什么算是Proprietary Information。怎么能够有效的保护这些
Proprietary Information啦。
如果真要谨慎的话,最好还是找个律师看一下你的NDA。最起码找个paralegal看一下也
好。
不怕一万,就怕万一。既然都到了签NDA来保护自己这一步了,那怕花点钱也值得吧。
h******s
发帖数: 3420
40
来自主题: Statistics版 - 统计硕士的出路
我是说director of biostatistics 20万,分四年。programmer 要少。每年50%
refresh. 难道大家以为我说的是20万/year?
我们公司是billion 了。去再小的拿的多一点,去再大的拿的少一点。
NDA 的确股票涨的快,几倍,几十倍的一般是有platform, 不停的file 新药,像
biomarin, Jazz pharma,Gilead 什么的.
这边一般在大公司攒点经验就去小公司。一般人喜欢赌merger, 2016 去medivation,
pharmacyclics, 去了几个月公司就被收购,一个个笑呵呵的等退休。
今年大家去cancer, 只要跟cancer 相关的股票一个个呼呼的涨,过两天一看被收购了。
搞这行不去小公司去哪儿?大公司都是卖现成的药,要biostatistician 干嘛?很多在
大公司干了十几年的没摸过NDA 的,好多公司只有registry.
而且大公司不是药过期就是被小公司打败,也就是cash 多靠买小公司过日子。不裁员
就不错了。今年allergen 股票都跌一半了,那硅谷的小公司才刚phase ... 阅读全帖
h******s
发帖数: 3420
41
来自主题: Statistics版 - 统计硕士的出路
我是说director of biostatistics 20万,分四年。programmer 要少。每年50%
refresh. 难道大家以为我说的是20万/year?
我们公司是billion 了。去再小的拿的多一点,去再大的拿的少一点。
NDA 的确股票涨的快,几倍,几十倍的一般是有platform, 不停的file 新药,像
biomarin, Jazz pharma,Gilead 什么的.
这边一般在大公司攒点经验就去小公司。一般人喜欢赌merger, 2016 去medivation,
pharmacyclics, 去了几个月公司就被收购,一个个笑呵呵的等退休。
今年大家去cancer, 只要跟cancer 相关的股票一个个呼呼的涨,过两天一看被收购了。
搞这行不去小公司去哪儿?大公司都是卖现成的药,要biostatistician 干嘛?很多在
大公司干了十几年的没摸过NDA 的,好多公司只有registry.
而且大公司不是药过期就是被小公司打败,也就是cash 多靠买小公司过日子。不裁员
就不错了。今年allergen 股票都跌一半了,那硅谷的小公司才刚phase ... 阅读全帖
m*z
发帖数: 2356
42
来自主题: _pennystock版 - 贡献几个生拉,然后老牛我就闭关
BIOD, 10月30号NDA,过不过的可能性50%,Reward/Risk相对较高。
CADX,11月4号NDA,应该没太大问题,上次没有只因为Manufacturing的问题而延期。过
的可能性75%, Reward/Risk一般,估计过了也就12-15块左右。
ALKS,9月16号Panel Review, 然后一个NDA,一个sNDA,Adam比较看好。公司的财务状
况很好。IMGN,估计NDA在明年2月左右,可能是下半年的一个明星。无论如何,大家小
心哟。
免责声明:生拉风险大,参见置顶文章,本人不负任何责任。
v**********m
发帖数: 5516
43
来自主题: _pennystock版 - PLX
瀑布了,但公司还是可以hold的。
大家说说入点吧。
now, it's 7.24
-------------------
http://www.reuters.com/finance/stocks/keyDevelopments?rpc=66&sy
FDA Issues Complete Response Letter To Protalix BioTherapeutics Inc.'s
Taliglucerase Alfa New Drug Application
6:30am EST
Protalix BioTherapeutics Inc. announced that the U.S. Food and Drug
Administration (FDA) issued a Complete Response Letter (CRL) regarding the
Company's New Drug Application (NDA) for taliglucerase alfa for the
treatment of Gaucher disease. Taliglucera... 阅读全帖
v**********m
发帖数: 5516
44
来自主题: _pennystock版 - Arna is a good buy?
Cash/share (Dec 30, 2010)
$1.13/share ($150,669,000/133,680,000)
-----------------------------------------------------------
刚增发过,到明年没问题。
Arena Pharmaceuticals Announces $35.5 Million Financing
- Arena to Use Approximately $17.7 Million of Proceeds to Prepay Outstanding
Debt -
SAN DIEGO, March 29, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (
Nasdaq: ARNA) announced today that it has agreed to sell 12,150,000 shares
of its common stock, at a price of $1.46 per share, and 12,150 shares of it... 阅读全帖
v**********m
发帖数: 5516
45
来自主题: _pennystock版 - dcth怎么看
如果历史重演,下两周会有10-15% 的小波来迎接FDA的接受信或据信。
如果1)DCTH的管理层不是太猪头,2)这个会议确实再今年1月份开过(我没有再DCTH
公司的网站查到确切的消息),那么FDA非常可能再10月12日或15日宣布给与DCTH快速
审批。
等FDA决定是否接受后,再讨论DCTH的走向;另外千万注意DCTH在等FDA的决定前增发股
票。
各位见好就收。
======
after consultation with a variety of experts and the FDA, we have agreed to
include the addition of the Generation 2 filter in the NDA as a technical
change as part of the CMC or Chemistry, Manufacturing, and Control module.-
Delcath Systems 's CEO Discusses Q2 2012 Results - Earnings Call Transcript
====... 阅读全帖
G****s
发帖数: 3523
46
【 以下文字转载自 JobHunting 讨论区 】
发信人: wolver (没有), 信区: JobHunting
标 题: 给作者: 报google nyc offer,并分享面经
发信站: BBS 未名空间站 (Sat Mar 19 15:12:23 2011, 美东)
同学,
(这是关于你的置顶文章, 本来因该私人信件的,但是给后来者一个警告也好)
First, you should know that you have signed an NDA with Google at the
beginning of the on-site interview and things that were said and discussed
during the interview (particularly the interview questions) were covered
under the NDA.
第一,你应该知道你面试的时候签过NDA,所有面试过程中说的都是覆盖的,尤其是这
些面试题目。
Second, you are already doing damages ... 阅读全帖
j***h
发帖数: 4412
47
【 以下文字转载自 JobHunting 讨论区 】
发信人: Ginobili (潘帕斯雄鹰), 信区: JobHunting
标 题: [合集] 也不要真把人家爆出来了
发信站: BBS 未名空间站 (Sun Mar 20 03:45:04 2011, 美东)
☆─────────────────────────────────────☆
lopt (好好学习天天向上) 于 (Sun Mar 20 03:06:33 2011, 美东) 提到:
希望她不要去告密就足够了。支持版主。
☆─────────────────────────────────────☆
wuyeliuxing (午夜流星) 于 (Sun Mar 20 03:06:56 2011, 美东) 提到:
没错,是这样。
☆─────────────────────────────────────☆
done (折埋) 于 (Sun Mar 20 03:10:42 2011, 美东) 提到:
对。
其实这本来不会是什么事,本来那个w善意提醒一下就可以了,但他非要把它搞大,我
觉得现在yy... 阅读全帖
w********d
发帖数: 34
48
wolver 的恐吓信。
☆─────────────────────────────────────☆
wolver (没有) 于 (Sat Mar 19 15:12:23 2011, 美东) 提到:
同学,
(这是关于你的置顶文章, 本来因该私人信件的,但是给后来者一个警告也好)
First, you should know that you have signed an NDA with Google at the
beginning of the on-site interview and things that were said and discussed
during the interview (particularly the interview questions) were covered
under the NDA.
第一,你应该知道你面试的时候签过NDA,所有面试过程中说的都是覆盖的,尤其是这
些面试题目。
Second, you are already doing damages to Google before you even started.
On... 阅读全帖
b*****n
发帖数: 6324
49
来自主题: Military版 - zz华尔街中国人不抱团儿 (转载)
经典代表性文章,再读一次!
【 以下文字转载自 JobHunting 讨论区 】
发信人: wolver (没有), 信区: JobHunting
标 题: 给作者: 报google nyc offer,并分享面经
发信站: BBS 未名空间站 (Sat Mar 19 15:12:23 2011, 美东)
同学,
(这是关于你的置顶文章, 本来因该私人信件的,但是给后来者一个警告也好)
First, you should know that you have signed an NDA with Google at the
beginning of the on-site interview and things that were said and
discussed
during the interview (particularly the interview questions) were covered
under the NDA.
第一,你应该知道你面试的时候签过NDA,所有面试过程中说的都是覆盖的,尤其
是这
些面试题目。
Second, you are already ... 阅读全帖
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