What We Need From the Agency
Long term follow-up. Long term follow-up in AIDS trials has been a disgrace. Even before the accelerated approval regulations were rewritten, few sponsors fulfilled their post-marketing requirements.
Virtually none of the major PI toxicities were identified before, or even shortly after licensure (lipodystrophy, CVD, Insulin resistance, etc)
In some cases (e.g. AZT myopathy) toxicities were not clear until years after approval. This is not acceptable.
Especially in Salvage patients, where there may be no virologic indication of response, it will be important to see if there is clinical benefit anyway, or conversely, if treatments are just killing people