Replies to post #831 on Cyclacel Pharmaceutical Inc (CYCC)

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Orphan Status verified on the FDA website:

Here is some information about what Orphan Status means...

CONGRESSIONAL FINDINGS FOR THE ORPHAN DRUG ACT

The Congress finds that...

(1) there are many diseases and conditions, such as Huntington's disease, myoclonus, ALS (Lou Gehrig's disease), Tourette syndrome, and muscular dystrophy which affect such small numbers of individuals residing in the United States that the diseases and conditions are considered rare in the United States;

(2) adequate drugs for many of such diseases and conditions have not been developed;

(3) drugs for these diseases and conditions are commonly referred to as "orphan drugs";

(4) because so few individuals are affected by any one rare disease or condition, a pharmaceutical company which develops an orphan drug may reasonably expect the drug to generate relatively small sales in comparison to the cost of developing the drug and consequently to incur a financial loss;

(5) there is reason to believe that some promising orphan drugs will not be developed unless changes are made in the applicable Federal laws to reduce the costs of developing such drugs and to provide financial incentives to develop such drugs; and

(6) it is in the public interest to provide such changes and incentives for the development of orphan drugs.

Here is a link to the FDA site that explains a lot more about this subject:

http://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/overview/ucm119477.htm

As you can see, Sapacitabine was granted Orphan Status for the treatment of myelodysplastic syndrome on June 24, 2010 and this is VERY GOOD news for CYCC...IMO

The image below is found here:

http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=263408

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The date on that article is May 29, 2008 and is from Europe...

The information I'm posting is from today on the FDA website...