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nidan7500

02/03/19 3:44 PM

#180316 RE: nidan7500 #180295

New FDA guidance document for trails. I have posted here what I call..."A2-73 ERP Objective evidence for Early Approval Clause." Also, please review section IV.

For special considerations related to use of biomarkers as surrogate endpoints, see section VI.,
Efficacy Endpoints.

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is thought to be able to predict clinical benefit but is not by itself a measure of clinical benefit. Effects on some surrogate endpoints (e.g., blood pressure, low-density lipoprotein cholesterol) are well established predictors of clinical benefit for certain indications and are regularly used as the basis for traditional approval of drugs. Less well established surrogate endpoints, but which are considered reasonably likely to predict clinical benefit, may be used as a basis for accelerated approval for treatment of serious or life-threatening diseases



https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM629579.pdf?rel=0

Bourbon_on_my_cornflakes

02/04/19 10:52 AM

#180406 RE: nidan7500 #180295

Trading tighter than a snare drum head.

ADXS up .06 on 34K shares. No way for any large short to cover without paying up.

And any good news will be like throwing nitroglycerine into a bonfire.

Definitely dont want to be short ADXS now.