BLA Acceptance for Tanezumab

Hi All

i have been watching this thread for about six months, but this is my first post. PAR is easily my biggest holding.

My question here relates to Tanezumab, which I noticed everyone has discounted as a potential competitor drug because it was said to have failed its Phase 3 on safety concerns. This was also stated in the latest updates on livewire a few days ago. However, when I did a google search on Tanezumab, there are articles or releases from Pfizer and Lily on 2 March this year that indicates that the FDA accepted a submission of a Biologics Licence Application for Tanezumab (is this the same as NDA?).

One such link is posted below, but you could google for other mirroring links


https://www.thepharmaletter.com/article/pfizer-and-lilly-announce-tanezumab-bla-accepted


What does this mean? I know that the AEs will mean that iPPS would be more likely to be the preferred treatment, but it might not stand alone as a treatment if this is approved.