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Synonyms for Cr

a hard brittle multivalent metallic element

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Evaluate how long a Complete Response Letter is likely to delay approval.
This release contains forward-looking information that involves substantial risks and uncertainties regarding REMOXY, including its potential benefits and Pfizer's effort to address the issues set forth in the FDA's Complete Response Letter concerning REMOXY.
In accordance with FDA guidance, Discovery Labs expects that it will be notified within 14 days that the Complete Response is deemed "complete" and the classification of the submission, which, under the Prescription Drug User Fee Act, will determine the target action date (PDUFA date) for the FDA to complete its review of the SURFAXIN NDA.
In going forward, we have one goal in mind: to thoughtfully and thoroughly address FDA's remaining concerns as outlined in the March 2010 Complete Response Letter so that we may best facilitate the approval of our lead product," stated Paul Goddard, Ph.
Errol De Souza, Biodel's president and chief executive officer, stated: "We plan to meet with the FDA as quickly as possible to discuss their comments in the complete response letter, clarify their requests for new information and determine our path forward.
A Complete Response Letter 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 complete response letter from the FDA cites deficiencies with the chemistry, manufacturing and controls (CMC) section of the BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS) (Medication Guide and Communication Plan).
In the most recent Complete Response Letter, the FDA stated that the Silenor NDA did not meet the approval standard for efficacy due to a lack of robustness of sustained subjective sleep maintenance efficacy in adults with primary insomnia.
The primary endpoint of the open-label, non-randomized STAR-1 trial is to determine the rate of durable complete response for tamibarotene therapy when administered as a single agent to adult patients following treatment failure with all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO).
Genmab A/S announced today that 55% of patients with relapsed or refractory follicular Non-Hodgkin's Lymphoma (NHL) treated with HuMax(TM)-CD20 achieved a clinical response in the Phase I/II study, including two complete responses and one unconfirmed complete response for a 27% complete response rate.
Nasdaq:ABIO) announced today that it received a Complete Response letter from the U.
The primary clinical endpoint in each trial was complete response, defined as the percentage of patients that did not experience vomiting or use rescue medication during the 24-hour period following chemotherapy.
NASDAQ:AMAG) today announced that it has received a Complete Response letter from the U.
The complete response rate was 29% on day 43, and 29% of the patients survived to day 120.
BiRD Study (Biaxin[R]-Revlimid-Dexamethasone) Provides Evidence of Deep Complete Response Rates In Newly Diagnosed Multiple Myeloma
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