The tables are clearly stacked against small biotech companies developing cancer drugs. History has shown that few (if any) have successfully had the Food and Drug Administration approve a late-stage cancer drug. While mid-stage trials of Galena Biopharma's (NASDAQ: GALE ) HER2-targeting breast cancer vaccine have been promising thus far, the chances of an approval seem a long way off.
In phase 1/2 trials the recurrence rate was reduced to just 5.6% in the NeuVax arm compared to a 25.9% recurrence rate in the control arm after a 60-month period. However, the split patient pool for these vaccines was relatively small (187 people) and it will take an additional three years to determine whether NeuVax meets its primary endpoint of disease-free survival once the phase 3 study is full. Including an FDA panel review and FDA PDUFA decision, we could be looking at 2017 before NeuVax even has the slightest chance at hitting the market.
Also, nearly Galena's entire pipeline is made up of some trial involving NeuVax, so a failure here could be a potentially big blow to shareholder confidence. This is a situation where I'd like to believe NeuVax could succeed, but there are viable reasons -- and a three-year wait -- to believe that this valuation is far from deserved.
Gee I purchased several that made me wealthy, maybe i should give up?? Lol This stock is a gold mine, good management, i like the hires they've made and FDA will approve it. They are approving drugs with less success than this one. Abstral was a great move! Sour grapes on a bad day is for losers. If you can't take the heat, be patient and feel confident with your research than try something else. This stock will either be bought out soon or be a bigtimer in 2-3 years.
The Motley Fool article is written by the same people that originally could not understand the difference between HER2 expression levels, depicting Neuvax as being researched for use in HER2-positive patients (which it is not) and what this product does....It is meant for treating HER2-low expressors, thus it would not currently compete with HER2 positive products like Herceptin as others may have you believe. It is hard for me to respect an article from a person or group that cannot distinguish this fact in the first place. In fact, it must be looked as a hack-job and is disgraceful when you think about the patients this would potentially benefit, if all holds true. I expect better from Motley Fool in particular, and think everyone should be careful on any opinions from this group as being nothing more than self-serving. The company has a market cap way under the potential for just this one drug, especially in comparison to many other biotechs, and has the potential for multiple catalysts going forward that can take place over the short-term. HER2-postive patients make up roughly 20-30 percent of the breast cancer population in the US alone, HER2-low expression thus, represents roughly 70-80% of the breast cancer population. If you are in it only for the money, would you have invested in Genentech and Herceptin in the pre-release years? How much could you be worth now? Obviously biotechs are risky....but do your OWN research.
This is what I don't get, people buy and sell based on these ridiculous articles online, l understand there will always be investors going long or short on a stock, but so many of these making comments on this message board get excited when this stock goes down 10-15 percent like its a big hit, you just have to be patient and let the Wall street games play out, in the not so distant future we (longs) will be very well off! Be patient!!!