Vertaling van "no request " (Nederlands → Frans) :

The tender offer materials may be obtained at no charge by directing a request by mail to Morrow & Co., LLC or by calling toll-free at (800) 607-0088 or (203) 658-9400, and may also be obtained at no charge at www.pfizer.com and the website maintained by the SEC at www.sec.gov.
The tender offer materials may be obtained at no charge by directing a request by mail to Morrow & Co., LLC or by calling toll-free at (800) 607-0088 or (203) 658-9400, and may also be obtained at no charge at www.pfizer.com and the website maintained by the SEC at www.sec.gov. Additionally, any questions related to the tender offer may be directed to Morrow & Co., LLC at the mailing address or telephone numbers provided above.

scope and purpose: 10/12 stakeholders involvement: 8/16 rigour of development: 7/28 (methods available only on request) clarity and presentation: 8/16 applicability: 3/12 editorial independence: 2/8 question: adequate search: insufficient selection: unclear quality appraisal: fair data-extraction: not given characteristics of original studies: not given meta-analysis: no pooling Randomisation: good concealment of allocation: no Blinding of outcome assessors: unclear Baseline characteristics comparable: yes Follow-up: sufficient Intention-to-treat: yes Contamination: unclear
scope and purpose: 10/12 stakeholders involvement: 8/16 rigour of development: 7/28 (methods available only on request) clarity and presentation: 8/16 applicability: 3/12 editorial independence: 2/8 question: adequate search: insufficient selection: unclear quality appraisal: fair data-extraction: not given characteristics of original studies: not given meta-analysis: no pooling

The FDA discussions focus on product labeling and Risk Evaluation Mitigation Strategy (REMS) as well as a safety update, but no request for more clinical studies.
Les discussions de la FDA portent sur la notice du produit et sur la stratégie de la gestion des risques (Risk Evaluation Mitigation Strategy ou REMS) ainsi que sur la mise à jour des données sur son innocuité, mais ne requiert pas plus d’études cliniques.

Afinitor (everolimus, RAD001), an oral inhibitor of the mTOR pathway, is currently expected to receive a regulatory decision for patients with advanced kidney cancer from the FDA in the first quarter of 2009 after the action date was extended by three months in late 2008 (no request for additional studies).
Afinitor (évérolimus, RAD001), inhibiteur par voie orale de la voie mTOR devrait être autorisé par la FDA au premier trimestre 2009 pour le traitement de patients atteints d’un cancer avancé du rein après que la décision a été repoussée de trois mois à fin 2008, sans que des études complémentaires aient été demandées.