the FDAs priority review procedures
Fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process.
If a drug is intended for the treatment of a serious or life threatening condition and the drug demonstrates the potential to address unmet medical needs for
the condition, the drug sponsor may apply for FDA fast track designation. The designation offers the sponsor opportunities for interactions with the FDA review
team and the possibility of a rolling review for certain portions of the marketing application. We believe that A4250 may meet the criteria to be designated as a fast
track product. However, even if we seek and are granted a fast track designation for A4250, there is no assurance that A4250 will receive marketing approval from
the FDA or that approval will be granted within any particular timeframe. We may also seek fast track designation for other current or potential future product
candidates of ours. Even if the FDA grants fast track designation to one or more of these product candidates, we may not experience a faster development process,
review or approval compared to conventional FDA procedures. In addition, the FDA may withdraw fast track designation that may in the future be granted to any
of our product candidates if it believes that the designation is no longer supported by data from our clinical development program for that product candidate. Fast
track designation alone does not guarantee qualification for the FDAs priority review procedures.
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Daher für mich alles im grünen Bereich.... |
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