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s17gator

02/24/13 10:14 PM

#39320 RE: stervc #39317

stervc'u are the king of DD....and thank u very much ....cheers to you....
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ganxiaohui

02/24/13 10:20 PM

#39321 RE: stervc #39317

so is not 30days we have to wait for 60days ????
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Pian0wire

02/24/13 10:20 PM

#39322 RE: stervc #39317

So the 30 day tIme period is only for approval of the NID application. This is separate from the 60 day Orphan Drug approval....correct? Thanks for all the DD sterv. Greatly appreciated!
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cowboydancer

02/24/13 10:34 PM

#39325 RE: stervc #39317

Awesome Brother, True FDA Facts, No Hype, No Pump !!!

Regen BioPharma / BMSN HemaXellerate I Did Not Happen Over Night !!!

Regen BioPharma / BMSN Put Together A Team Of Experts To Submit

The Investigational New Drug (IND) Application to the FDA.

HemaXellerate I product is the only therapy that has potential to simultaneously block the underlying cause of aplastic anemia while at the same time rebuilding the bone marrow tissue that has been damaged by the disease."

If the clinical trial is successful, the company plans to expand use of HemaXellerate Ito other conditions associated with bone marrow dysfunction, with the overall goal of entering the hematopoietic growth factor market. This market is substantial in size and currently includes drugs such as Neupogen®, Neulasta®, Leukine® and Revolade®.

"Current drug-based approaches for healing bone marrow damage involve "flooding" the body with growth factors, which is extremely expensive and causes unintended consequences because of lack of selectivity," said Dr. Vladimir Bogin, CEO of Chromos Pharma (a contract research organization), which collaborated with Regen on filing the IND and member of the Company's Scientific Advisory Board. "Based on our data HemaXellerate I possesses the advantage delivering an optimized cellular mixture that produces the needed growth factors at the specific location in the bone marrow niche."

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razelle

02/28/13 9:07 AM

#41421 RE: stervc #39317

stervc: Good morning, Can you please comment on what your thoughts are on BMSN today on the BMSN board? It seems that there is speculation on FDA approval for BMSN. How sure are you that BMSN will be approved? I know your research is extensive and you are well read on everything BMSN. Your opinion matters on BMSN board.