Below is a link to a drug the FDA just approved to slow Alzheimer's, 27% of people got some benefit and the side effects are not great to say the least, however it has been fully approved.
Our OSA candidate had a significantly higher reduction of OSA - we all the know the numbers, and very low to nil adverse side effects.
So if we are to create a drug for OSA that is FDA approved and reduces OSA by say 30% with no to very few side effects, I think we are a very very very high chance of getting it approved by the FDA. If a Dr says, take this tablet and you should atleast improve your sleep quality by 30% with low side effects, are your giving it a crack? (If we are are the first OSA drug approved by the FDA it comes with 7 years exclusivity).
Yes people can go and lose weight and do all sorts of thing to help OSA, but lets face it, people want the easy fix which is why these weight loss drugs has gone absolutely nuts (ie Wegovy and Ozempic). Again the side effects don't sound great.
The likes of Bob Clarke who know the FDA process has obviously seen something in this and 675a that leads him to believe they are both a very good chance of approval. (His remuneration is almost completely tied to this belief).
They already work - we know that, they are combination drugs that are prescribed on their own already. Dronabinol is prescribed for OSA, acetazolamide for mountain sickness, Plaquenil is used for RA already and CBD is a very powerful anti inflammatory drug.
Our tests so far show the combos seem to work better than these on their own and we are expanding our IP coverage all over the world.
We need the trials to now back this up, but one thing for both 42 and 675 that makes me very comfortable is their safety profiles, if they work on a larger group better than the individual components, I remain very very confident the FDA will approve them.
IHL Price at posting:
10.5¢ Sentiment: Buy Disclosure: Held
