Rich Pharmaceuticals Inc. (fka RCHA)

[stervc]

RCHA Expects FDA Orphan Drug Fast Track Approval…

Per the CEO of RCHA below:

http://wallstreetanalyzer.com/rich-pharmaceuticals-otcqbrcha-ceo-chairman-and-president-ben-chang/

Below are some thoughts I previously shared a while back from what I have learned about getting FDA Fast Track Approval for Orphan Drug submission with the FDA:

Guidance for Industry Expedited Programs for Serious Conditions – Drugs and
Biologics
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf

On Page 8

On Page 29…

Per the FDA, before a company can get FDA Fast Track Approval, they must ”FIRST” submit an Investigational New Drug (IND) application for their drug. As you can see from below, RCHA submitted its IND back in Oct 2914:

http://finance.yahoo.com/news/rich-pharmaceuticals-announces-completion-manufacture-144500701.html
Rich Pharmaceuticals submitted its Investigational New Drug (IND) Application for a Phase 2 multi-center study to evaluate the safety and efficacy of RP-323 in patients with AML and MDS in October 2014. In connection with the IND, Rich Pharmaceuticals was required to manufacture sufficient quantities of RP-323 under GMP.

The FDA Fast Track Approval usually only takes 60 days, which confirms that RCHA is way overdue. Think about it like this… from mid Oct 2014 to mid Nov 2014 is the 60 day time frame for a response. You usually know anytime within the 60 day response time frame if you are going to get FDA approval or not because the FDA is required to let you know if anything further is needed by them for you to re-submit. From what I had learned, from this original submission back in Oct 2014, the FDA had requested that they go back and manufacture sufficient quantities of RP-323 under GMP. As you can see from the PR they recently released above, they have fulfilled that FDA requirement to manufacture sufficient quantities of RP-323 under GMP. Read below to read more about the FDA Fast Track Approval Process for an Orphan Drug.



What I am about to explain is from an earlier conversation I had with the FDA that might help to add a little more clarity. This was when I was educating myself about another stock I was in a little while back that was attempting to get to this level of where RCHA is. Please, anyone can call the FDA Office of Orphan Products Development (OOPD) and ask questions about what I am about to state. They will confirm that there is a 60 day approval process for drugs that are approved to be an Orphan Drug like I had originally learned from previous articles and from researching info from the FDA website. Based on key timelines within the recent RCHA PR below, I think that we can expect FDA Approval soon:

http://finance.yahoo.com/news/rich-pharmaceuticals-announces-completion-manufacture-144500701.html
Currently, the new study drug is in the final examination stage at Wuxi Apptec and is expected to be shipped to clinical sites starting mid-February 2015 for the upcoming planned clinical trials.

This is a very subliminal hint that something has been confirmed and approved. Please understand, this is not actually coming from RCHA; this is coming from their partner, WuXi Apptec (WX:NYSE), who are the ones who submitted the drug back to the FDA. This is a huge shot pf credibility versus being submitted by RCHA. This is because WX:NYSE is a company that trades at $40.00+ per share with a $2.8 Billion Market Cap that generates over $670 Million in Revenues:
http://www.wuxiapptec.com/about_us.html

http://finance.yahoo.com/q/ks?s=WX+Key+Statistics
http://finance.yahoo.com/q?s=wx&ql=1

I think it is important to first clearly understand that RCHA has already submitted their IND which will help RCHA to obtain FDA Approval for Orphan Drug Status which allow RCHA to "bypass the lengthy Phase I, II, III, & IV FDA Approval Processes". This is what will bring an "accelerated Phase I, II, III, & IV FDA Approval Process" that will be part of RCHA performing some sort of clinical trials.

I was specifically told by the FDA Office of Orphan Products Development (OOPD) that the company will probably have to first get IND approval for their drug then it will be sent to their office soon after to be awarded Orphan Drug status. I was never given a direct time frame, but I was told that the FDA tries to get everything done much quicker when obtaining Orphan Drug Status is on the line.

My learning of this "60 day" time frame was originally derived from the link I researched from an article below:

http://minnesota.publicradio.org/display/web/2010/08/05/orphan-drugs
...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. ...

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:
http://www.youtube.com/watch?v=-sKFl5lAmJE



FDA Small Business Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069906.htm

FDA Investigational New Drug (IND) Application
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm

FDA What Is an Orphan Drug?
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107293.htm

FDA Guidance for Industry Expedited Programs for Serious Conditions – Drugs and
Biologics
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf

RCHA**Clinical Trials and the FDA Approval Process
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=110623125

Federal Grants can be given to support Orphan Drugs as explained below:
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm

v/r
Sterling