This is the reply I got from Generex when I inquired about the IND trials:
As a follow up to Rose Perri conversation where you discussed the use of Generex Oral-lyn™ in the U.S.A, I am sending you information on the buccally absorbed regular recombinant human insulin product and attached fact/information sheets on the FDA approved Treatment IND program available in the United States. Additional Treatment IND information is also available at www.generextxind.com and www.clinicalTrials.gov.
Below is a brief description of the buccally absorbed insulin.
Generex Biotechnology Corp. has developed an insulin which is delivered as a spray to the oral mucosa from where it is absorbed directly into the circulation. It is a human recombinant regular insulin for prandial use and is called Generex Oral-lyn™. It is currently used by patients (Type 1 and 2) who have difficulty or cannot take injectable insulin for prandial glucose control. It is currently approved by FDA in the United States under the Treatment IND program for use by patients who have difficulty using conventional insulin treatments.
Generex Oral-lyn™ is an easy, needle-free insulin treatment for patients requiring control of prandial glucose excursions. 1 spray is approximately equivalent to 1 unit of regular injectable insulin. Even though it is a regular human insulin, it is rapid acting (behaves like an analog) due to its area of absorption. The onset of effect is within 15 min, its peak effect in approximately 30 min and total duration of effect is approximately 2 hrs. Once at baseline again, it shows no tail therefore has no stacking effect or chance of hypoglycemia. Due to its short action (total of 2 hrs) it is versatile in its uses. It is primarily intended for prandial use, however, it can also be used between meals for glucose control as long as a 2 hr window of effect is available.
Should you be interested in pursuing approval for the use of Generex Oral-lyn™ through the Treatment IND program, please contact me at the below listed contact information and we will be happy to guide and assist you through the process.
Should you have any other questions, please e-mail me at email@example.com or phone at 416-364-2551 Ext 228.
I also have an attachment in the email that includes a .zip file