On October 8, 2021 Dr Joey posted this........
3. Add ACER deal - this is going to happen! Next June, ACER-001 has a 90% chance of approval rating right now. It has been accepted (big deal and 2month process alone from submission to announcement of official acceptance). It is going in under section b (505) meaning it's applying for an ALREADY APPROVED DRUG with modifications to it (that do not affect its effectiveness). In other words, the drug is already approved as safe, effective, beneficial for the conditions for which they are submitting the application. The bar is very low here for these types of drugs under section b (505). You only have to prove by bioequivalence. Basically, the hard part is over. In layman's terms, ACER put a hard candy shell on the outside of the same nasty drug that patients have been refusing and spitting out for years because of the taste. They hard part to get this ACER-001 drug approved was just proving that once the pill passes the palate and into the stomach, and the hard candy shell dissolves, does the drug amount available to be delivered equal the same amount of available drug as did the original nasty stuff once it made it to the same stage of digestion. Also, does their manufacturing processes to make the drug yield pure bioequivalent substance of the same sanitary quality as the original already approved drug. Obviously, they are past out of this. Now they will meet to discuss marketing and aftermarketing observation methods for the drug before user fees are applied (for which they won't have to pay these either because MSUD has already received ODD status! That means a $2.9mil amt that stays in the pocket!).
AI
