Thanks Trding! You always seem to find relevant ar
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Posted On: 04/06/2019 1:03:28 PM
Thanks Trding! You always seem to find relevant articles to the topics discussed somehow!
It seems hard to believe this is only a recent change within the past 5 years. I understand the need to make sure a drug is safe, but if previously proven seems like some of the data could be streamlined. I know many drugs do not have the same safety profile as leronlimab and looking at different indications and combining with other drugs may have safety impacts, but IMO leronlimab should see fast approval for cancer if clinical trials prove efficacy.....based on the quote from your article below:
“The agency may now grant full approval to a supplemental new drug application using an intermediate endpoint on a case-by-case basis. One reason is because we weigh the urgency of an unmet clinical need.”
It seems hard to believe this is only a recent change within the past 5 years. I understand the need to make sure a drug is safe, but if previously proven seems like some of the data could be streamlined. I know many drugs do not have the same safety profile as leronlimab and looking at different indications and combining with other drugs may have safety impacts, but IMO leronlimab should see fast approval for cancer if clinical trials prove efficacy.....based on the quote from your article below:
“The agency may now grant full approval to a supplemental new drug application using an intermediate endpoint on a case-by-case basis. One reason is because we weigh the urgency of an unmet clinical need.”
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