BNHLF (MC $33 M) BLA Filing for BIG Bladder Cancer vaccine in this Quarter =500%+ Potential

[aqaqayi]

BNHLF (MC $33 M) BLA Filing for BIG Bladder Cancer vaccine in this Quarter .

Runup to FDA decision and Approval could drive this Stock close or over $2 per Share ! GL


Market Cap: $33 Million
Cash: $10 Million

Price: $0.19

[asojoxoomebed]

Bioniche is not only expected to apply for market approval in Q1 2015, but it has already submitted an application to the FDA for Orphan Drug Designation which would give Bioniche 7 years of market exclusivity in the US.

While this company has been well under the radar, Lahiri says, "Odds are Bioniche will obtain an Orphan Drug Designation soon and FDA market approval by next year, enabling them to capture a sizeable market share in the $1 billion addressable bladder cancer market."

[ArthurLarl]

"Telesta is a late stage therapeutics company with near term commercial potential focused on a unique specialty drug (MCNA) for non-muscle invasive bladder cancer. The drug has completed a phase III study and the Company expects to file its biologics license application (BLA) with the FDA in Q1 of 2015.

During 2014 there were 74,690 new cases (15,580 deaths) of bladder cancer in the United States with 70%-80% of these being non-muscle invasive. There has not been a new treatment for this type of cancer approved by the FDA since 1998. With greatest lifetime treatment cost per diagnosed patient currently at $230,000, the approval of MCNA by the FDA creates a significant opportunity for the Company. MCNA addresses an unmet medical need as it could be an alternative to radical cystectomy for patients.

The US FDA has reviewed the Company's clinical data and is supportive of a BLA filing with no additional trials. MCNA is a high margin biologic opportunity for Telesta that will be priced as a premium oncology product. The market size has been validated by an independent 3rd party and this market is significant.

The Company has very strong intellectual property coverage allowing for market exclusivity potential to 2031."

[Barchart.com]

Im sure that we will see higher share price than the PT below of $1.25 before FDA decision .GL