RE:RE:RE:RE:My questions and a response from Frederic40 wrote: They are analog. 4050 family are compound that target different receptor in an antagonist or agonist way.
Think of it as a tomato sauce recipe. One as more pepper, the other one more salt than the other one and taste a little different but they all are a tomato sauce at the base.
analog of 4050 are different compound so they have to go with phase 1 -2 -3 for safety pk etc.
however, since they are just a few tweak from the original recipe, they shows the same safety on animal trail. Also, the tweaks on the compound makes it more efficient on some fibrotic receptor for the kidney or the lung etc depending if there is more salt or more pepper! So we can assume that even if mandatory, phase 1 will go smooth, but has to be done with the regulatory timeframe.
However, we can assume that the FDA review might be faster as it is an analog they will already understand and be familiar with. BUT that is right that all the trials have to be done for every analog
Eric and Closly, as we were sitting at the same table, isn't there that we were told that 4425 was scoring even better than 4050 in NASH?
Anyway, as they are different molecule, we will have to go in phase I clinical trial for any different molecule and start from scratch.
I don't see them like tomatoes, but like mushroom. And 2 musherooms can look exactly alike, but one of them can kill you!!!