$PPCH - Development Plan - Once lead development
Post# of 8672
Posted On: 05/20/2014 8:48:56 AM
$PPCH - Development Plan - Once lead development product selected, the Company plans to undertake early stage clinical development of PRP
1. Steps include: Meet with regulatory authorities to discuss non-clinical & clinical development plans
1. Development of manufacturing process & drug substance
1. Initiation of pharmacology and toxicology studies
1. File regulatory submission and then conduct twelve month PH I safety study in patients with advanced carcinoma
1. Initiate discussion with potential licensing partners prior to and during PH I
1. Steps include: Meet with regulatory authorities to discuss non-clinical & clinical development plans
1. Development of manufacturing process & drug substance
1. Initiation of pharmacology and toxicology studies
1. File regulatory submission and then conduct twelve month PH I safety study in patients with advanced carcinoma
1. Initiate discussion with potential licensing partners prior to and during PH I
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