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Posted On: 02/08/2020 12:11:11 AM
Post# of 148984
my favorite part of the article and especially when Nader said all patients in the investigational trial had to complete a year during the CC.
BLA Filing: The filing had been pushed back by a month after the FDA asked them for more safety data. Initially the FDA was fine with 50 patients, but wanted an additional 595 from the CD03 trial. Amarex committed to enter in the data as quickly as possible for a premium price. Most would view this development as a negative, but it is quite positive because the additional safety data makes the BLA completely sound on the safety. This robust safety profile greatly increases the likelihood of Breakthrough Therapy Designation (BTD) approval. The data also paves the way for a very quick monotherapy approval without additional trials because the data subsets overlap by a huge amount making the case; how can you approve one without the other because the data sets are almost identical.
BLA Filing: The filing had been pushed back by a month after the FDA asked them for more safety data. Initially the FDA was fine with 50 patients, but wanted an additional 595 from the CD03 trial. Amarex committed to enter in the data as quickly as possible for a premium price. Most would view this development as a negative, but it is quite positive because the additional safety data makes the BLA completely sound on the safety. This robust safety profile greatly increases the likelihood of Breakthrough Therapy Designation (BTD) approval. The data also paves the way for a very quick monotherapy approval without additional trials because the data subsets overlap by a huge amount making the case; how can you approve one without the other because the data sets are almost identical.
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