Loosely related to NP's upcoming BTD meeting with FDA, there was a very interesting article out today about IMMU and their triple negative breast cancer drug - the article states that because of manufacturing issues identified by the the FDA, IMMU's drug is unlikely to be approved at its June 2nd PDUFA. This should be a reminder to all of us as to why the manufacturing section of of our BLA is so very important, and as to why we should be so glad that NP did not rush submitting this final piece to the FDA just to meet the timeframes previously verbalized to us shareholders!