Lexaria Bioscience Corp (LEXX)

[Bluetikiman]

While the tech does require changing the manufacturing process of the drug in question, it's not changing the active biological compound within the final product. It's like liquigels verse capsules. Advil sels 200mg ibuprofen in both conformations, but one is a gel capsule with a liquid suspension of the active compound while the other is a hard pill with a sugar outside. Your body breaks them down at different rates, but the drug is the same.

I doubt they had to go through a full FDA approval process to make the switch to gel caps. Now I'm sure there are some safety related things they were obligated to show for the gel caps, but nothing as stringent as a new 510k submission.

The big question is whether the fact that the method of entry in to your blood stream may be different with Dehydratech compared to other versions of the compound would require a full FDA submission and approval process... I'm inclined to say that it won't be required since the active compound is the same as before. I could be wrong though