RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:CoverageMake the argument, then, minedigger. Make the arguement. I attacked your comment, fair and square. You attack me. You gotta learn to separate your argument from yourself - your anonymous self. And this case, it wasn't even your argument. You essentially cut and pasted it without explanation or further research. I argued against it, meaning that I argued against whoever made that argument, which certainly was not you.
About the last word, you'll can have the last word when you can wrap a considered opinion with a graceful benediction.
Just a few points about phase 3 and big/small companies:
- With FDA "Breakthrough" status, xB3-001 may never need to go through phase 3. Straight to market, post phase 2.
- With over 20 years of use, Herceptin is extremely well known with respect to target engagement, biomarkers, pharmacokinetics, pharmacodynamics, efficacy, mechanism of action (MOA).
- Because Herceptin is so well known, the behaviour of xB3-001 in the periphery and in the brain can be monitored with the detail that few new drugs in clinical trials can otherwise be monitored. (That would give FDA confidence in their "breakthrough" decision, whichever way that goes.)
- Many small companies do not take their drugs to phase 3. Instead, many of the best drugs are bought up by the big companies, or partnerships are entered for late-stage trials. That creates a huge bias in favour of large company P3 success compared to small company success.
- I would contend that none or damn few of the small companies taking drugs into P3 are doing it with drugs that have been approved and on the market for years like we see with Bioasis and Herceptin.
- Many small companies have no place to go but into clinical trials. They must do it or their funding, jobs and companies will likely disappear. That MAY mean that some small companies go into late stage trials with drugs that large companies would have dropped either in preclinical or early clinical stages.
So, minedigger, if you want to make the argument that would lump Bioasis into that "small company" bunch of failures, I would like to hear it. But remember, that if I argue about that kind of casino-type of statistic, I'm taking on the argument, not you.
That whole small vs big company "argument" is bogus. It may be a statistical truth, but it's not a predictor. It's certainly not a predictor with respect to Bioasis and xB3-001.
But thanks for raising it. It gave me a chance to discuss many other things, including how fundamentally unique and promising that the xB3 peptide really is, and that the transport of already approved and medically successful drugs across the BBB reduces, in clinically measureable ways, the medical and financial risks usually inherent in clinical trials.