CRL or Approval???, page-51

Yep I agree for the kids suffering from this it should be a no brainer and for their sake I hope it goes through. However spl had a fastrack approval for female bacterial vagenousis fda said no safety or production issues, unmet need for millions of american women. Still knocked it back no reason given why? Who knows never explained, 2 years later approved aus,nz,europe,uk, asis and 40 countries proven great saviour to women with bv lauded only thing that works. SPL spent12 years getting this to fda approval should have been a gimme yet knocked back two years almost still not approved yet selling over half the world please explain? Big money? Big business who knows all I am saying take nothing for granted with the FDA. gltah and kids