GALE: Importance of the NeuVax Interim Analysis
The upcoming interim analysis is monumentally important to the company. The only reason Galena has NeuVax is because large pharma and biotech VCs wouldn't take the "risk" of funding NeuVax's Phase 3 trial since the Phase 2 trial was not conducted under "commercial trial standards". Big pharma and biotech VC's wanted to see NeuVax repeat its Phase 2 trial, but this time under "commercial trial standards". If the outstanding Phase 2 trial results were repeated, NeuVax would have easily attracted the interest of both big pharma and biotech VCs. NeuVax did not repeat its Phase 2 since the FDA had already granted NeuVax a Phase 3 Special Protocol Assessment (SPA). As a result, NeuVax has been carrying the baggage as being a "researcher's data-mined" drug candidate for years.
Fast forward to today. Galena is within a few days/end of Q2 of knowing if the interim results are positive. The Independent Data Monitoring Committee (IDMC)'s recommendation of whether or not to continue the trial will be the FIRST indication that NeuVax is working in a setting which meets the "commercial trial requirements" required by big pharma and the top-tier biotech investment community (that have been risk-adverse up to this point). A positive interim result on NeuVax's Phase 3 study will be transformational to the company's financing and commercial licensing efforts. Assuming a positive signal from the IDMC, for the first time, NeuVax will be the prettiest girl at the dance and highly sought after by big pharma and top-tier investors. ...And this is just a few days/end of Q2 away...
AI
