More from Seeking Alpha Article. Seeking Alpha Article>>>>>>>>The results were very encouraging: - Regarding efficacy, the overall 1-year disease-free survival rate increased significantly. Durable responses were also observed, as well as a noticeably lower rate of progression and cystectomies in patients who responded to MCNA as compared to those who did not respond. - In terms of safety, the results showed that intravesical administration of MCNA was well tolerated, with most adverse events being mild to moderate in severity and few leading to discontinuation of treatment. In a high-risk, BCG-failure patient population where limited treatment options beyond a surgical removal of the bladder are available, MCNA, characterized by a clinically meaningful activity and excellent safety profile, appears to be a superior alternative to patients who are unfit for or who decline a surgical removal. MCNA should be approved The final goal is, of course, to obtain the FDA's market approval. Biotech stocks are known to soar tremendously upon obtaining such an approval, so what are the chances for Bioniche? Statistics seem to favor Phase III biotechs. Studies show the odds of a drug passing the Phase III trials and getting on the market stands at approximately 50% on average. This bodes well for Bioniche, but it's gets even better. Two very positive milestone developments recently occurred: Development number 1: FDA allows fast-track route for market approval The FDA reported Bioniche is allowed to file for market approval just based on Bioniche's existing clinical trial data set, management itself thought they need to conduct another Phase 3 Study (second leg). In other words, the results were so good, that the FDA allowed to speed up the process with fast-track. Read this link to learn more about the FDA's fast-track options, and how beneficial it could be for respectively the company developing the drug and the medical community desperately waiting for new medical innovations. Bioniche expects to file in Q1 2015. If the FDA gives the thumbs up, shares will absolutely skyrocket overnight. Development number 2: Filing for Orphan Drug Status Shortly after, Bioniche filed an Orphan Drug submission. An Orphan Drug Designation is a key milestone in the path to full commercialization. An update is to be expected within 60 days from now. This is an important near-term catalyst, which could drive shares substantially higher. Keep in mind that Bioniche has already successfully completed the first leg of the Phase III trial. So based upon this information, I estimate the odds of approval to be at least 80%. Such a high likelihood is very hard to find in the biotech space, especially with such an off-the-radar stock as Bioniche. Also, the high unmet medical need regarding bladder cancer should encourage the FDA to approve MCNA. Experts across the board report that the unmet need in the bladder cancer market has reached critical levels, both in the early-stage, non-muscle invasive bladder cancer and the late-stage muscle-invasive and metastatic settings. Little progress has been made over the past 10 years that has significantly changed the treatment for patients or provided more efficacious treatment options. MCNA addresses a $1 billion unmet medical need A couple of interesting statistics to update you on bladder cancer: •An estimated 75000 new cases of bladder cancer will be diagnosed and about 16000 deaths from bladder cancer will occur in the United States each year. •Bladder cancer was the ninth most common cancer in the world, with 430,000 new cases diagnosed in 2012. •Bladder cancer is the fourth most common cancer in men. •the cost from diagnosis to death is one of the highest of all cancers ranging from $96k to $187k per bladder cancer patient. The market size for the US and 5 European countries is currently estimated at $240 million, and projected to grow to $300 million by 2017. In the Asia-Pacific region, the market will approach $1 billion in size. Globally, it's fair to assume the market opportunity is already $1 billion, and is projected to double in 5 years. Again, bladder cancer is for a large part an unmet medical need, and the medical community is more than eager to adopt new therapy methods. Overall, Bioniche appears to be sitting in a pole position to capture sizeable market share. The bladder cancer market is virtually free of competition