Posted On: 09/12/2013 10:24:19 AM
Post# of 5066
I Hell post. BMSN.
Excellent post. And just to keep it into perspective on how BMSN could not only get FDA approval but "Orphan Drug Designation" and for those not aware what this means, it simply means $$$$ for smart investors!
"1. Regen has already filed one non-provisional patent application and is preparing to file two more based on research conducted in support of Its IND application.
2. The clinical trial proposed in our IND is based on using a drug product derived from the same patient, for stimulating production of new blood cells in aplastic anemia patients for which other treatments have failed.
3. Demonstrating proof of concept in this patient population will not only provide a potential Orphan Drug designation, but also will allow entry into other conditions associated with failure of the bone marrow to produce blood. This market is substantial in size and currently is addressed by biological drugs such as Neupogen®, Neulasta®, Leukine® and Revolade®." BMSN.
Excellent post. And just to keep it into perspective on how BMSN could not only get FDA approval but "Orphan Drug Designation" and for those not aware what this means, it simply means $$$$ for smart investors!
"1. Regen has already filed one non-provisional patent application and is preparing to file two more based on research conducted in support of Its IND application.
2. The clinical trial proposed in our IND is based on using a drug product derived from the same patient, for stimulating production of new blood cells in aplastic anemia patients for which other treatments have failed.
3. Demonstrating proof of concept in this patient population will not only provide a potential Orphan Drug designation, but also will allow entry into other conditions associated with failure of the bone marrow to produce blood. This market is substantial in size and currently is addressed by biological drugs such as Neupogen®, Neulasta®, Leukine® and Revolade®." BMSN.
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