inspirator schreef op 15 juli 2014 19:42:
Vandaag mail ontvangen van FDA.
Vermeende weigering van 'approval' Ruconest is in scene gezet.
Niemand is hiervan op de hoogte.
Koers 'onterecht; lager gezet; op basis van feiten koers Pharming zo weer 1 euro hoger.
Thank you for writing to the Division of Drug Information in the Center for Drug Evaluation and Research (CDER).
Please note that under the law (21 CFR 314.430), the FDA cannot comment on investigational drugs, proposed clinical trials in the U.S. or drugs pending approval as this information is considered confidential for the company. You may wish to contact the sponsor directly for information on the status of their product.
Sincerely,
SS
Drug Information Specialist
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration