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v**********m
发帖数: 5516 | 1 瀑布了，但公司还是可以hold的。
大家说说入点吧。
now, it's 7.24 | b*****h
发帖数: 783 | 2 现在进如果接飞刀感觉晚了，等他们resubmit下一轮又太早了。。
【在 v**********m 的大作中提到】
: 瀑布了，但公司还是可以hold的。
: 大家说说入点吧。
: now, it's 7.24
| v**********m
发帖数: 5516 | 3 下星期也许还会往下探探。
【在 b*****h 的大作中提到】
: 现在进如果接飞刀感觉晚了，等他们resubmit下一轮又太早了。。
| v**********m
发帖数: 5516 | 4 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. Taliglucerase alfa is a plant-cell expressed
form of glucocerebrosidase (GCD). A CRL is issued by the FDA's Center for
Drug Evaluation and Research when the review of a file is completed and
questions remain that preclude the approval of the NDA in its current form.
The main questions raised by the FDA regarding the NDA relate to clinical
and chemistry, manufacturing and controls (CMC). In the clinical section,
the FDA requested additional data from the Company's switchover trial and
long-term extension trial. At the time the NDA was submitted, full data from
these trials was not available. In the CMC section, the FDA requested
information regarding testing specifications and assay validation. On
November 30, 2009, Pfizer and Protalix BioTherapeutics, Inc. entered into an
agreement to develop and commercialize taliglucerase alfa. Protalix will
request a meeting with the FDA as soon as possible to clarify the path to
regulatory approval. Patient enrollment remains open in Protalix's multi-
center, double-blind pediatric trial of taliglucerase alfa. Patients
currently enrolled in the switchover study and extension study will continue
to receive the drug. | b*****h
发帖数: 783 | 5 现在进如果接飞刀感觉晚了，等他们resubmit下一轮又太早了。。
【在 v**********m 的大作中提到】
: 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
| v**********m
发帖数: 5516 | 6 下星期也许还会往下探探。
【在 b*****h 的大作中提到】
: 现在进如果接飞刀感觉晚了，等他们resubmit下一轮又太早了。。
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