Why there is only 5% dropout in India, but so high dropout in European??? Why Generex do not ask trial money back???
Generex should not ask shareholder reduce their shares!!!
Refuse Reverse split, CEO should step down!!!
For this study in the prespecified non-inferiority margin was 0.50%. The 90% confident centre ball to that range of values defining the difference between two parameters. It’s calculated to be 0.24% to 0.53% since the 0.50 non-inferiority margin is in between the upper and lower values of confidence centre ball. The study was not able to show that Generex Oral-lyn was non-inferior and is equal to the injected human insulin. The extremely low number of patients completing their trial directly affected the values of the confidence centre ball. But even with that huge dropout the upper limit of the 90% confidence centre ball was very close to the pre-specified non-inferiority margin of 0.50%.
Study almost was successful. In sharp contrast, the phase three trial conducted in India a series of Shreya Life Sciences, is an excellent example of the way a trial should be conducted. This study, 12-week parallel control study comparing Oral-lyn and injected rapid insulin in patients with type two diabetes was conducted at fourteen sites in India with 209 patients put on drug. The educational materials and the informed consents were translated into nine different languages so that each individual persists that in his or her representatives could read the information in a language in which they were conversant and comfortable.
In this study only 11 of the 209 subjects, 5% dropped out of the trial. While the manuscript of the full trial results has been submitted to an international journal of clinical diabetes and thus the detailed results are embargoed into a publication. I can share that there was a statistically significant improvement in the hemoglobin A1c of those patients planned to Oral-lyn compared to injected insulin.