My limited experience with these trials seems like it has been in the rear view mirror. They have evolved since I first started following the HCV trials in 2004, very actively in 2006 (Prove 1) was in in a Vertex Phase 3 (Prove-3)trial in 2008 (I dropped out before dosing), and was in ION-1 (Sov/Ledi/RBV)last year. I stopped my dosing exactly one year ago.
Point is, every time there has been a new trial, I've been bamboozled trying to figure out what the drug company was going to do, cause every time the FDA changed things. (generally speaking those changes have been beneficial to speeding up the approval process)
I was really surprised when there was no FDA Phase 2 trial for 7977 (sovaldi) and ledipasvir; it went right to phase 3 based upon correlating daclatasvir structure so similar to Ledipasvir (GS-5885)
...... or for some reason; whatever it was the two drugs were not dosed together in phase 2 so far as I recall.
It seems to me that the drugs being offered today are so much safer, tolerable than what was offered that the FDA is being far more open to taking some liberties that were not taken in the past.
Here is the principle I would float out; they may or may not be transparent about what they require.
We may see it in advance of the trials, or we may see it and infer it only when the trials are designed, and we have to infer what happened.
This is where watching clinical trials will provide an answer, or tweets, or stock pitches.
Frankly, a lot of this is too esoteric for many of us investors, the retail chumps like me, so reading and having it explained in a forum such as this is a SERVICE and a benefit of reading forums.
Thank you. : )
I freely admit that in spite of my experience in HCV trials, that I am a novice, have no idea what the FDA will do, and only have some passing knowledge about some of what they have done. : )
