wollte ich heute ein bisschen mich bei fannie und Freddie austoben und habe auch geglaubt, dass wir die 5 antasten. Mit den News gehts aber hier ordentlich ab. Hab mein depot mal seit langem mit Ariads (allerdings über Tradegate) aufgefüllt. Ich bin gespannt wo es hingeht heute ...
If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request.
Iclusig ist doch schon zugelassen? Was heißt das jetzt hier?
Doch wieder first-line?
Das wäre ja wirklich der Hammer!
What are the benefits of a breakthrough therapy designation?
Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
A breakthrough therapy designation conveys all of the fast track program features (see below for more details on fast track designation), more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. Section 902 of FDASIA requires the following actions, as appropriate:
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