entirely new trial request indicates that amarex sabotaged way more data than we realize? cant believe the FDA will trash 10 years worth of SAE free patient data, with undetectable HIV, with zero side effects when all current available - advertised on tv - medication has significant side effects. but they have surprised me in the past.
and yes, this all did take substantially longer than anticipated, which were certain entities plan all along, in order to populate the "new drug landscape" with their drugs first.
will the FDA declare that the "new drug landscape" is chock full of HIV options that a new safer drug is not needed? i always thought that a new drug that achieves the same result, but has lesser/no side effects would immediately be approved. i could be wrong. i have been in the past.
im going to believe the new trial protocol request is a new and additional trial, for a new patient pool, which is positive news, and the past trial data will be salvaged and approved for the indications they were trialed for. the FDA can not have been reviewing years of data and suddenly decide that amarex/NP was blowing it all along. i could be wrong, i have been in the past.