The FDA is what it is, we can’t change them. We

The FDA is what it is, we can’t change them. We have to find a way to navigate this so there process does not become a roadblock. Many years ago I felt strongly the GvHD indication should have been put first. The reason is not that there is much revenue, but because it is a great base hit. Imagine if all other indications were built on an already FDA approved drug? The big problem now is we have a long list of huge indications with no approval on any of them. BP would not care if we were to take over the GvHD market, and would not realize we were heading to bigger things. The FDA, BP and investors look at the big claims of this drug and the reaction is prove it, because that sounds a little too sensational. The David vs Goliath scenario could have been avoided if our hunger could have been tempered to what we could realistically achieve.

Most small biotechs get bought or partnered with around phase 2, if they are at the phase 3 stage they failed to get partners at phase 2. That in my opinion is the second mistake made, we did not team up at phase 2 years ago in HIV. I am very hopeful that we are getting second chances with cancer and Nash. I don’t think about how long until approval for either, I think about the eyes on this drug at this phase.

I don’t feel we should slow roll some indications, I just think the self evaluation and realistic goals are in the back set to chasing the new shiny thing. Covid has the climate to bypass a difficult process because it is a pandemic, however we have somehow found a way to take the shortcuts and end up on the long road. However, I can’t stress this enough, this is a very unique situation. How many drugs are this safe, this effective against so many indications and under the umbrella of a tiny company run by a mechanical engineer? Do any of us really think what has been done so far is wrong? You can’t know because this is so bizarre.