I think it will be neutral with a positive bent for now until full Phase III results are released - then watch out! The market and diabetics are waiting for full Oral-Lyn enrollment and determination if the product works, period. Things to note:
(1)There has never been an adverse reaction in all the years of testing.
(2) The product uses existing insulin rather than a reformulated version so the drug doesn't have to be approved, only the delivery device.
(3) The competition, Mannkind (MNKD), had been 6 months ahead of GNBT but is now 15 - 24 months behind. The FDA required additional testing from MNKD to ascertain their second generation device was biocompatable with their original device. Unlike GNBT, MNKD uses a reformulated insulin.
(4) In SMALL tests it was observed Oral-Lyn doesn't produce antibodies like injections. If confirmed by larger studies, this is tremendous as diabetics who don't mind injections may have to convert to Oral-Lyn.
(5) Oral-Lyn was accepted for the FDA IND program which makes available drugs before formal approval for special groups of patients who have no other viable alternatives. This is the ONLY diabetic drug to enter the program and close to 100% of all drugs in this program eventually get approved. I would imagine that the FDA already looked at preliminary results to include Oral-Lyn in the program.
(6) The delivery device is a platform capable of delivering many different types of drugs. This is especially important for drugs going off patent as a new delivery for the drug would extent patent protection.
(7) The cancer vaccine appears to work.
(8) The US Army is testing the vaccine.
(9) Generex will probably need additional capital although a partnership would possibly be non-dillutive.
(10) The company has a bunch of really heavy hitters advising them. Why would they put their reputations behind this? They think this will work, help people, and make money. The bottom line is either it works or it doesn't.
