Yes you are correct Sunshine has done years of research.
I was referring to them going through the necessary clinical phases.
Sunshine Pharma is just getting started to move to HUMAN testing.
The testing they have been doing is preclinical studies which to date have been extremely positive.
What is next will determine just how solid these studies are.
Adva-27a Clinical Trials Plans
Adva-27a’s initial indication for Phase I clinical trials will be pancreatic cancer. We are planning to conduct our clinical trials at McGill University’s Jewish General Hospital in Montreal, Canada. All aspects of the planned clinical trials in Canada will employ FDA standards at all levels. We estimate that it will take approximately 18 to 24 months from start to finish. Following successful completion of Phase I clinical trials, it is likely that we will be required to make Adva-27a available to patients under the “compassionate-use” guidelines.
FDA drug approval pathway
Preclinical studies—animal models; safety profile
Investigational New Drug Application to conduct human trials submitted to FDA
Phase 1 Clinical Trial—safety profile, dosage
Phase 2a and 2b Clinical Trials—safety and efficacy
Phase 3 Clinical Trials—Pivotal large-scale studies to acquire data for FDA approval
New Drug Application for marketing product submitted to FDA
AdCom meetings—expert independent panelists review
PDUFA date—FDA decision on approving a drug for market
Traditionally, pharmaceutical product development companies must first perform preclinical work with animals to establish that the drug is safe before applying to conduct human clinical studies. The company can then submit an Investigational New Drug (IND) application to the FDA. Once the FDA has greenlighted human studies, the drug then must pass through three phases of clinical trials in which the company must obtain sufficient data to prove safety and efficacy.
At the conclusion of each clinical phase, the data is submitted to the FDA. The regulatory body will then make a decision as to whether or not the drug is a viable candidate for the next clinical phase. The completion of Phase 3 data moves the drug candidate to the final stage of the approval process, the Prescription Drug User Fee Act (PDUFA) meeting date.
