FDA.gov website5 May 2018 17:58
From the fda.gov website. Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.
Benefits of Lupuzor>>> Lupuzor™ demonstrated a superior response rate over placebo* (52.5% vs 44.6% “responders”**) in the primary analysis on the Full Analysis Set of all 202 patients (including withdrawals who are considered non-responders). However, due to a high response rate in the placebo group, this superior response did not allow statistical significance to be reached (p = 0.2631) and the trial’s primary end point was not met.
Lupuzor™ also demonstrated a superior response rate over placebo (68.8% vs 59.2%) in the 153 patients who completed the study (p value not currently available).
Importantly, in patients who had anti-dsDNA autoantibodies (a recognised biomarker for Systemic Lupus Erythematosus (‘SLE’)), Lupuzor™ demonstrated a superior response rate over placebo (61.5% vs 47.3%, p = 0.0967). In addition, 7.6% of these patients in the Lupuzor™ group went into full remission versus none in the placebo group. >that’s the benefits, now here comes the risks >>>>
The study confirmed the outstanding safety profile of Lupuzor™, with zero serious adverse events reported. Now make up your own mind from the facts above if the fda will allow Lupuzor to go on sale.
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