Posted On: 09/05/2013 9:44:23 PM
Post# of 5066
BMSN. Post by PoPo.
Orphan Drug Status/Investigational New Drug Application for HemaXellerate is moving along at a perfectly normal pace. I know alot of people believe it is taking too long, and for those of you who are getting impatient (as was I until I did some digging) take a look at one of the only examples we have to look at how long it SHOULD take.
Pluristem (currently trading at $3.00/share) applied for Orphan Drug Status for its PLX Cell Treatment for the treatment of Aplastic Anemia (precisely what HemaXellerate is for) in August of 2012. The PLX Cell Treatment was ALREADY an approved treatment and was ALREADY an orphan drug for Buerger's Disease at that time. It took until nearly the end of February 2013 for it to receive the orphan drug designation.
BMSN applied for Orphan Drug Status/Investigational New Drug for HemaXellerate in February of 2013. We are just NOW at the same length of time it took Pluristem to get Orphan Drug Status for a treatment which ALREADY had Orphan Drug Status for treatment of a different condition. Keep in mind that this is also the FDA's first look at HemaXellerate as it is not already an approved treatment (much less an Orphan Drug at this point).
Keep it real. Stay positive. These things take time as they should.
Orphan Drug Status/Investigational New Drug Application for HemaXellerate is moving along at a perfectly normal pace. I know alot of people believe it is taking too long, and for those of you who are getting impatient (as was I until I did some digging) take a look at one of the only examples we have to look at how long it SHOULD take.
Pluristem (currently trading at $3.00/share) applied for Orphan Drug Status for its PLX Cell Treatment for the treatment of Aplastic Anemia (precisely what HemaXellerate is for) in August of 2012. The PLX Cell Treatment was ALREADY an approved treatment and was ALREADY an orphan drug for Buerger's Disease at that time. It took until nearly the end of February 2013 for it to receive the orphan drug designation.
BMSN applied for Orphan Drug Status/Investigational New Drug for HemaXellerate in February of 2013. We are just NOW at the same length of time it took Pluristem to get Orphan Drug Status for a treatment which ALREADY had Orphan Drug Status for treatment of a different condition. Keep in mind that this is also the FDA's first look at HemaXellerate as it is not already an approved treatment (much less an Orphan Drug at this point).
Keep it real. Stay positive. These things take time as they should.
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