I don’t get why a company that has jumped through all the hoops has all the data and statistical significance with 350 mg dosing can’t say to FDA “no wait why would you request change of dosage information? that’s not what we were working on we have combo/350 mg with statistical significance and superiority to competition ...let’s go with that so at least it gets done! WHY?! Why?? We would have revenue and an approved product !
Why do companies have to buckle when they have a clear path forward??
As much as believe in LL the grief one experiences trying to fathom the FDA and all their Tom foolery is truly shocking!! That IMMU slogged it out for 37(? can that statement be correct) years to get one product approved is mind boggling on so many levels. Scott Kelly so adroitly pointed this out maybe he was trying to say, hey gang we are doing ok all things considered , but in the very same passage he starts jabbering about Blood/brain barrier and more indications!!! Just nail down one bloody indication!! ....but no they are just adding more for every CC. Sorry for the rant suffering investor fatigue in the middle of a pandemic we can end....I have to get another hobby this is making me crazy........LONG....LONGER.