Generex Biotechnology Corp. (fka GNBTQ)

[WeeZuhl]

Pharmaceutical-grade L-glutamine (PGLG) for sickle cell disease.


http://www.prnewswire.com/news-releases/emmaus-new-drug-application-for-sickle-cell-disease-accepted-for-review-by-fda-300358916.html

Data from the company's Phase 3 sickle cell disease trial demonstrated a reduction in the frequency of sickle cell crises and hospitalizations, as well as a reduction in cumulative days hospitalized, and a lower incidence of the life-threatening acute chest syndrome. The clinical trial enrolled 230 adult and pediatric patients as young as five years old, across 31 experienced sickle cell disease treatment centers in the U.S. No major adverse events were attributable to the treatment. If approved, this represents the first potential treatment for pediatric patients with sickle cell disease, and the first potential new treatment in nearly 20 years for adult patients.

http://www.prnewswire.com/news-releases/emmaus-life-sciences-receives-notice-of-fda-pdufa-date-for-investigational-l-glutamine-treatment-for-sickle-cell-disease-300369546.html

Emmaus Life Sciences, Inc. announced today that the U.S. Food and Drug Administration has set a PDUFA date of July 7, 2017 for a decision on the Company's New Drug Application for its orally-administered pharmaceutical grade L-glutamine (PGLG) product for the treatment for sickle cell disease.