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biopharm

09/08/17 12:13 PM

#311154 RE: hutschi #311149

Immuno-oncology (I-O) drugs such as Merck & Co's Keytruda and Bristol-Myers Squibb's BMY.N Opdivo, which help the immune system attack tumours, can have dramatic effects and yet only around 20 to 30 percent of patients show a lasting improvement.



I took only one piece out of your Sept 8 2017 fresh as morning strawberries, which proves how awful FDA SOC IO drugs actually are....and the FDA may have scientific evidence SOON on how to fix the problems of HALTED trials which will increase due to gross negligence that can be filed against the FDA if they do not get quickly up to speed on learning how to tell via BIOMARKERS what helps the immune system and what does not help....(up to 80% of patients in Opdivo and Keytruda ...and their families would be stricken with disbelief knowing that biomarkers and cross analysis data may help transform FDA safety protocols ...increase responders ....decrease off target TOXICITIES...etc etc


By Thomas M. Burton
Sept. 7, 2017 12:41 p.m. ET

FDA Modernizing Evaluations as Gene, Cell Therapy Fields Grow
Commissioner says one step agency will take is conducting early scientific conversations with startup and small biotech companies

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Food and Drug Administration commissioner Scott Gottlieb said the FDA is hurrying to modernize the way it evaluates a flood of new drug applications derived from the fast-growing fields of gene and cell therapy.

In a talk Thursday before a coalition of corporate and academic research ....

https://www.google.com/amp/s/www.wsj.com/amp/articles/fda-modernizing-evaluations-as-gene-cell-therapy-fields-grow-1504802513