RE:Two items stick out from a re-read of it allTH 's biggest ally might be President Trump who many times has seeked to change how FDA vets new drugs by speeding up the slow and burdensome process....I agree with SPCEO that reason should prevail especially as BFW has stated many times the first priority is do no harm !!!!!
Egrifa is safe ,,,,
But I am not predicting any outcome ,,,,,the odds of favorable FDA response are between 0 % and 100%.....
Wino115 wrote: Taking into account all the discussion here, I re-read everything. Two things stuck out.
1. There is a strong statement in the Lancet piece on fibrosis resolution. Prior to this sentence they say the following: "Fibrosis stage is the strongest predictor of mortality in patients with NAFLD, and FDA guidance on treatements for NAFLD stresses the importance not only of liver fat reductions, but also of prevention of fibrosis and reduction of inflatmmation." So they are placing this in the context of the FDA treatment guidelines for NAFLD (not NASH per se). Then,
"...Moreover, reductions in liver fat were associated with reductions in fibrosis in a population with strictly defined NAFLD."
This is clearly from the biopsy data as this disctinction preceeds the statement. Isn't this a pretty darn strong statement that they did see resolution of fibrosis in the strictly defined group? That would answer a pretty significant question.
2. We haven't talked about what the placebo group showed them. But twice (in Lancet and Lancet editorial) this statistic is mentioned. "A large percentage (38%) of HIV patients with NAFLD in the placebo group show progression of fibrosis over 1 year.....This highlights the crucial need for a therapy to prevent fibrosis progression in this population."
In other words, left untreated, within 12 months you get the scenario the FDA specifically is saying you should try to prevent. If exercise and diet won't help you prevent it, you need something else. Twice this statistic was mentioned so I think that's what they'll use to show you can't do nothing. At that rate, it would mean in the 3 years of the trial, 100% of HIV patients with some form of fibrosis will graduate to at least one, maybe higher further degrees of fibrosis. Pretty interesting stat.