BOT - Anything but charting, page-10412

Yes, Botanix said it in an announcement.
It's their job to make it sound exciting and I'm not saying it isn't.

"The first and only new approved chemical entity..." since Qbrexza.

Novel means new and original.
In reference to FDA approval, it means not approved or marketed in the US for anything before.
Yes, it's an achievement, but doesn't itself increase the chances of it being better or more successful than an existing treatment.

I asked where you sourced your statement from. - "FDA approves only if your drug is min 25 to 30% better then one before."