I have been in NVAX for three years, as my first purchases were in May and June of 2013. This is my largest holding and the one I follow the most closely.
I am cautiously optimistic that they will achieve statistically significant results in their Ph3 trial for elderly RSV vaccine, "Resolve", especially since the FDA worked with them to design the primary objective of prevention of moderate-severe RSV-associated lower respiratory tract disease, as defined by the presence of multiple lower respiratory tract symptoms. This was in contrast to the Ph2 trial, which had a primary outcome of reducing the incidence of respiratory illness due to RSV.
Getting FDA approval of this vaccine for RSV in the elderly population would be a huge victory for the company. Any follow-on indications, like the maternal and pedi population that they're working on, is icing on the cake. Aside from that, their combo respiratory vaccine (quadrivalent flu + RSV) would be their next game changer. Their prior studies in their flu vaccine alone were impressive enough.
Overall, I'm pretty bullish on their prospects; but I may take a little off (hopefully before trial results if I can guess timing correctly) and a little more off if they have successful Ph3 results. I'm sure there will be a pop on good data followed by a correction until launch and financial results start to be revealed.
Other factors that might happen between Ph3 and launch are, obviously, announcement of an ex-US partner and/or buyout. Stan has stated over and over that they plan to go-it-alone (except for an ex-US partner), but I'm not convinced that they wouldn't sell for the right price.
They seem to have beefed up their manufacturing capabilities and can produce millions of vaccines, but they would have a better chance of robust financial results if they sold out to a large pharma like Pfizer, Novartis, Sanofi, GSK, Merck, or AstraZeneca. This is all stemming on successful Ph3 results, of course. Eventually, they would probably do more for their shareholders in the long-term if they didn't sell out and kept everything in house (except for ex-US), especially if their other trials pan out.
There would probably be hiccups and risk along the way like with a slow roll out, but I think they could meet the demand for the RSV vaccine. If shareholders were willing to hold and the company chose not to sell out, we'd be rewarded much more than selling out to a large pharma this year or early next.
