That money is for all of the required lab work, chemical analysis, product testing and materials listing, after Aug 8 every single thing ,must be documented and remain exactly the same as the current product on the market, any tiny change of any component will make the product a new product and the whole process would need to be repeated. They even covered software updates, so if a glitch is found to introduce a software update a brand new PMTA would be required. This money doesn't even go to FDA, it's the cost of TRYING to gather the required information for approval, and then there will be the application fees and yearly registration fees on top of all that, IF they decide that the product is good for the health of the general population, not even just the potential customers of the product, and the product must be shown to be not attractive to youth, whatever they decide that vague statement means.
So yeah, it's going to be impossible for any company in our industry to survive this as it stands.
