Rich Pharmaceuticals Inc. (fka RCHA)

[stervc]

Benefits of FDA Fast Track/Orphan Drug Approval...

I agree with your FDA Approval thoughts. The drug that RCHA has to fight cancer greatly qualifies for FDA Fast Track Approval. This drug by RCHA was manufactured and sent by WuXi Apptec (WX:NYSE) to the FDA for approval to be considered having Orphan Drug status. Benefits for RCHA and us shareholders with RCHA having drugs that are eligible to obtain Orphan Drug Status are indicated below:

1**60 days or Less Accelerated final/full FDA Approval.
2**Bypass lengthy Phase I, II, III, IV FDA Approval Processes.
3**The FDA has been offering incentives for developing treatments for rare diseases since 1983, when the Orphan Drug Act became law.
4**The FDA wants to double the number of orphan drug designations that their office approves in the next five to 10 years.
5**The Orphan Drug designation comes with a 50 percent tax credit on any clinical trials that need to be conducted.
6**Drug fees, which currently cost around $1.6 million for one drug application, are eliminated.
7**The company that succeeds in getting final FDA approval will be allowed exclusive drug marketing rights for seven years.
8**Major medical companies see “confirmed” future value to be 100% on board and supportive.
9**Dr. Cote says the designation brings the new drug to the attention of investors.

Below is a quote from Dr. Timothy Cote:

"When you get orphan status designation, you go up on our website saying that the FDA has given a nod that this is promising for this rare disease," said Cote. "And then the venture capital rains down from the heavens.

The U.S. FDA established the Orphan Drug Act (ODA) in []January 1983. For those wondering who is Dr. Timothy Cote, he is the doctor that is over the Office of Orphan Products Development. Read below an important article that highlights the importance of Orphan Drugs which supports RCHA in my opinion with quotes from Dr. Timothy Cote:

http://minnesota.publicradio.org/display/web/2010/08/05/orphan-drugs
…The FDA has been offering incentives to companies that develop treatments for rare diseases since 1983, when the Orphan Drug Act became law. …

…The FDA's Dr. Timothy Cote thinks there are many more researchers and companies who could benefit from the orphan drug designation. But he says they're often overwhelmed by the regulatory process.

"We have an opacity problem at the FDA. It's a big black box. Nobody knows what they're thinking inside," said Cote. "And we're smashing that black box. We're making it transparent and we're showing people that what we're doing is reasonable, that we don't bite, and we are just as interested in getting new drugs for people with rare diseases as the sponsors are."

Rare conditions are often described as orphan diseases when there are very few treatment options, largely due to a lack of money for drug research. There are about 7,000 known orphan diseases in the U.S.

Cote, who directs the Office of Orphan Products and Development, says most of those diseases have no approved treatment. For that reason, he wants to double the number of orphan drug designations that his office approves in the next five to 10 years. …

… The designation comes with a 50 percent tax credit on any clinical trials that need to be conducted. Drug fees, which currently cost around $1.6 million for one drug application, are eliminated. And a company that succeeds in getting final FDA approval will be allowed exclusive drug marketing rights for seven years.
But more than that, Cote says the designation brings the new drug to the attention of investors.
"When you get orphan status designation, you go up on our website saying that the FDA has given a nod that this is promising for this rare disease," said Cote. "And then the venture capital rains down from the heavens. That is how it has tended to work for a lot of these companies." …
… The FDA says it will rule on all of the applications it received while in Minneapolis within 60 days. Typically, between 55 percent and 70 percent of orphan drug status applications are approved.

Video of FDA Dr. Timothy Cote - Office of Orphan Products Development:

v/r
Sterling