Sunshine Biopharma Inc (SBFM): It's not phase 1. It's preclinical.-wron...

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Re: dranesthesia1 post# 32698

Tuesday, 09/20/2016 3:59:25 PM

Tuesday, September 20, 2016 3:59:25 PM

It's not phase 1. It's preclinical.-wrong again

The statement in the Purpose section of the CT record in the public Clinical Trials database is sort of a giveaway:

This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects with previously treated pancreatic ductal adenocarcinoma and will identify the maximum tolerated dose (MTD).

Also the little box underneath indicating "Phase 1" in the "Phase" category is a good status indicator. LOL

Pre-clinical means exactly that - before clinical humans trials. Required for FDA approval of an IND, and to start a clinical trial.

One needs only to understand how the FDA drug approval process works.

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