FACTS: In 4/03 XKEM goes for approval in Nigeria
for Niprisan/Hemoxin (known as Nicosan) for Nigeria. In sept. 03, XKEM seeks orphan drug status FDA approval and receives approval in the US for same. Now, XKEM has received orhan drug approval status in the US for 5HMF.
However, my understanding is that orphan drug status approval is only for a maximum need of 200,000 people or less. (Orphan drug status is usually designated for drugs to treat 200,000 people or less in the US). The US market for this drug 5HMF is then limited? Yes, Nigeria has +- 9 million possible afflicted with this diesase, but XKEM is only proceeding with the Nicosan drug product at this time there. I am not bashing the company only stating facts. Question as to what happened if this same drug (Nicosan) was already gone after approval in Nigeria in 03? And why isn't XKEM going after 5HMF approval there as well as in the US?
(Check Biospace.com website for particulars on any possible drug candidate)
As always, this is just opinion, please do your own due diligence.
Best Regards
