RE: valuation?22 Jun 2020 00:19
I was trying to make the point that if regulators let companies cut corners then it can end badly - both drugs have a place in therapy. Thalidomide I think is used to treat leprosy.
We are talking about using high doses of a pro-drug that get converted in a specific tissue. The proposition being this enables you to use higher doses.
That's fine if you give it to a rat and then sacrifice them. However, what you don't know is what happens to the drug after its been converted - has complicated pharmacy dynamics. Does it leach out into the systemic circulation where you are back to square 1, does it overwhelm liver metabolism, does it accumulate in other tissues. This then becomes more complicated because the issues you get using multiple course with dox might occur with pro-dox. Stefin A on which affirmers are based is also a biologically active molecule.
The differences in dose, the cardio toxicity, the FTIM nature makes me think (albeit with limited regulatory experience) that this is not a submit an library file on dox and hope that will do. We are also not condeming people to death - there are other treatments