RE: 200mg AVA 600013 Sep 2022 21:00
JT: I agree, we don’t know the true definition of ‘maximum exposure’. Icecool was repeating the FDA line, I could not respond.
I view the max line to be exposure to dox, therefore cleaved product. AVA6000 is not dox, therefore my view. I realise you know this.
I’m terms of dose, JT is correct. They need to escalate to understand how changes to dose are metabolised by the body. For instance; typical prodrugs show exponential exposure to the ‘drug’ (AUC) as dose increases. But maintain similar half-life. This data is important.