RE:RE:RE:Thoughts on why our phase II targeted a 40% efficacy....
A few facts:
- Valstar got appoval for a patient population with a contraindication to cystectomy
- Valstar got no approval for people just refusing cystectomy
- The choice of patient population depends mainly on efficacy not on AEs
- The efficacy of MCNA is not sufficient to justify a risk of 10-15% patients getting metastasis unless its patients choice to take the risk
- The Adcom was about approval for people fit for and potetially willing to undergo cystrectomy
- TST most likely has to narrow its indication for approval
- In the FDA briefing document the FDA discussed a CIS population with contraindication to or refusing cystectomy
- This is the indication that most likely will get approval
- The decrease in market potential by a narrower indication will be offset by off-label use due to BCG shortage
- Official NR providing clarity on narrowing indication most likely will propel share price
- KS is a dckhead w mental disorder
- Institutional buy in was at 0,306 CAD, SP below should be considered a buying opportunity
- This bullboard is no fun to read