RE:RE:RE:RE:RE:RE:How much study drug do we need? EnriqueSuave ... That's an interesting example. Thanks for sharing.
I know that when a pharma wants to combine 3 already existing pills in 1 for example, HC/FDA will force them to redo all testings (Ph. 1 for example) even though nothing changes in the overall quantities of all 3 individual pills. I just don't know though if they ask for shelf-life certification for that new 3-in-1 pill.
Because we would use 2
already approved drugs, then that's probably no issue to them then, as anyways, a Ph. 1b of GBM with Rutherrin will anyway have toxicology and tolerability as primary endpoints (*1). That's probably has nothing to do with shelf life stability.
Your explanation makes sense.
For sure, GBM would be more interesting to follow as it's a much more complex and challenging indication to tackle. The GBM indication is the one that had the most news released (9). TIME is the biggest issue with GBM. By the time patients are diagnosed and then treated, many die, as one neurologist once stated. And immuno-therapy drugs take too much time to kick in. PDT/PDC is instant. That's why we have an edge over them.
Exciting times ahead, no matter what.
*1:
Efficacy would only be exploratory, just like it was during our NMIBC Ph. 1b. __________________
enriquesuave - (12/3/2019 6:45:26 PM) RE:RE:RE:RE:RE:How much study drug do we need? A lot of compounded drugs are premixed at the hospital just before IV injection and hence no concern for shelf life and stability as premixing can be done an hour before. I don't know how they are proceeding here. But no worries , they know what they are doing.