@xxxmenxxx: welchen Bericht denn bitte? Du hast als Quelle einfach nur das „Bmsn Board“ auf ihub per googletranslate übersetzt. Jeder 10. Klässler kann das in einer besseren Qualität.
"ist nur Frage der Zeit bis der knall kommt...."
Der so genannte Knall ist das FDA Approval bezüglich des IND's. Danach, wie schon oben beschrieben, hofft man auf den Orphan Drug Status. Das Medikament "HemaXellerate I™" ist gegen "aplastic anemia" (spezielle Form von Blutarmut) was unter diese Status fallen könnte.
“The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.”
quelle: ttp://www.fda.gov/ForIndustry/...ductsforRareDiseasesConditions/default.htm
Vorteile des Orphan Drug Status:
"Designating an Orphan Product: Drugs and Biologics
The Orphan Drug Act (ODA) provides for granting special status to a product to treat a rare disease or condition upon request of a sponsor. The combination of the product to treat the rare disease or condition must meet certain criteria. This status is referred to as orphan designation. Orphan designation qualifies the sponsor of the product for the tax credit and marketing incentives of the ODA. A marketing application for a prescription drug product that has been designated as a drug for a rare disease or condition is not subject to a prescription drug user fee unless the application includes an indication for other than a rare disease or condition."
Quellewww.fda.gov/ForIndustry/...rphanProductDesignation/default.htm
Man muss euch Pusher echt im Zaum halten..