Replies to post #2921 on Rich Pharmaceuticals Inc. (fka RCHA)

[NoMoneyNoHoney]

If that happens as expected this month...watch out. Possibilities are endless.

[pawertz]

Excellent DD. I jumped in last week and have been adding as this situation has gotten clearer. Thanks Sterling, I (and the board, I'm sure) appreciate your quality work.

[Dragonwing]

Awesome DD Thanks

No fault of yours, but of course it's missing the one thing I'm looking for...

A link to the submitted Orphan Drug Fast Track Approval applications!

I've spent hours on that site and everything is many months old.

They don't post anything till the drug is on the shelves.

Just like this one but at least it says the phase II was completed last month.

https://clinicaltrials.gov/show/NCT01009931

[Da Ghost]

RCHA

stervc, where is the WX Press Release stating the FDA submission?

[OTCdoc]

Great post > Should hear something verrry soon i expect.....Geuss thats why i got in today.

[Helter Skelter]

Thoughts?

lOl...

[Da Ghost]

RCHA

Stervc, can you explain the PPS depreciation?

Apparently the DD here is flawed ;-) lolzzz

[mick]

great reading for 'Rich Pharmaceuticals Inc. (RCHA)'

RCHA Expects FDA Orphan Drug Fast Track Approval…

Per the CEO of RCHA below:

Quote:
--------------------------------------------------------------------------------

[mick]

RCHA recent news/filings

## source: finance.yahoo.com

Wed, 25 Feb 2015 20:01:47 GMT ~ RICH PHARMACEUTICALS, INC. Files SEC form 10-Q/A, Quarterly Report


read full: http://biz.yahoo.com/e/150225/rcha10-q_a.html
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Tue, 24 Feb 2015 22:13:25 GMT ~ RICH PHARMACEUTICALS, INC. Files SEC form 8-K, Unregistered Sale of Equity Securities


read full: http://biz.yahoo.com/e/150224/rcha8-k.html
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Mon, 23 Feb 2015 19:30:28 GMT ~ RICH PHARMACEUTICALS, INC. Files SEC form 10-Q, Quarterly Report


read full: http://biz.yahoo.com/e/150223/rcha10-q.html
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Mon, 23 Feb 2015 14:45:00 GMT ~ Rich Pharmaceuticals, Inc. Highlights 2014 Significant Accomplishments

[PR Newswire] - BEVERLY HILLS, Calif., Feb. 23, 2015 /PRNewswire/ -- Rich Pharmaceuticals, Inc. (OTCQB: RCHA) ("Rich Pharmaceuticals" or the "Company"), a clinical-stage biotechnology company focused ...

read full: http://finance.yahoo.com/news/rich-pharmaceuticals-inc-highlights-2014-144500972.html
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Wed, 04 Feb 2015 14:45:00 GMT ~ Rich Pharmaceuticals Announces Completion of the Manufacture of RP-323 Study Drug in Connection with Obtaining FDA's Final Approval of The Investigational New Drug (IND) Application For The Treatment of Acute Myelocytic Leukemia

[PR Newswire] - BEVERLY HILLS, Calif., Feb. 4, 2015 /PRNewswire/ -- Rich Pharmaceuticals, Inc. (OTCQB: RCHA) ("Rich" or the "Company"), a clinical-stage biotechnology company focused on developing ...

read full: http://finance.yahoo.com/news/rich-pharmaceuticals-announces-completion-manufacture-144500701.html
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$RCHA charts

basic chart ## source: stockcharts.com



basic chart ## source: stockscores.com



big daily chart ## source: stockcharts.com



big weekly chart ## source: stockcharts.com


$RCHA company information

## source: otcmarkets.com

Link: http://www.otcmarkets.com/stock/RCHA/company-info
Ticker: $RCHA
OTC Market Place: OTCQB
CIK code: 0001504389
Company name: Rich Pharmaceuticals, Inc.
Company website: http://www.richpharmaceuticals.com
Incorporated In: NV, USA

Business Description: Rich Pharmaceuticals is a biopharmaceutical company that is focused on the development of its lead product, TPA (12-O-tetradecanoylphorbol-13-acetate), for the treatment of acute myelogenous leukemia (AML) in refractory patients. The basis for the interest of the Company to pursue clinical development of TPA in this and possibly other indications is the result of the work of Prof. Richard Chang. He has conducted research on TPA for many years and has become an expert in the characteristics of this molecule. The findings form the scientific basis for the clinical use of TPA.Less >>



$RCHA share structure

## source: otcmarkets.com

Market Value: $877,942 a/o Feb 27, 2015
Shares Outstanding: 731,618,351 a/o Jan 31, 2015
Float: Not Available
Authorized Shares: Not Available
Par Value: 0.001
$RCHA extra dd links

Company name: Rich Pharmaceuticals, Inc.
Company website: http://www.richpharmaceuticals.com

## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=RCHA+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=RCHA+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=RCHA+Industry

## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/RCHA/news - http://finance.yahoo.com/q/h?s=RCHA+Headlines

## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/RCHA/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/RCHA/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=RCHA+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/RCHA
DTCC (dtcc.com): http://search2.dtcc.com/?q=Rich+Pharmaceuticals%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Rich+Pharmaceuticals%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Rich+Pharmaceuticals%2C+Inc.&x=0&y=0
WHOIS (domaintools.com): http://whois.domaintools.com/http://www.richpharmaceuticals.com
Alexa (alexa.com): http://www.alexa.com/siteinfo/http://www.richpharmaceuticals.com#
Corporate website internet archive (archive.org): http://web.archive.org/web/*/http://www.richpharmaceuticals.com

## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/RCHA
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001504389&owner=exclude&count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/RCHA/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/RCHA/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=RCHA&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=RCHA
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/RCHA/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=RCHA+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=RCHA+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=RCHA
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=RCHA
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=RCHA+Cash+Flow&annual

## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/RCHA/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=RCHA+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/RCHA.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=RCHA
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/RCHA/insider-transactions

## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/RCHA
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/RCHA
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/RCHA:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=RCHA
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=RCHA

[Zer0Veritas]

Fast Track approval and RCHA could hit .10+ easily

[mick]

huge reading/ RCHA recent news/filings

## source: finance.yahoo.com

Tue, 24 Mar 2015 12:35:00 GMT ~ Rich Pharmaceuticals, Inc. Announces Letter of Intent with Faculty of Medicine at Khon Kaen University to Conduct Acute Myelocytic Leukemia Clinical Trials

[PR Newswire] - BEVERLY HILLS, Calif., March 24, 2015 /PRNewswire/ -- Rich Pharmaceuticals, Inc. (RCHA) ("Rich Pharmaceuticals" or the "Company"), a clinical-stage biotechnology company focused on developing innovative therapies in oncology, with initial concentration in treating Acute Myelocytic Leukemia (AML) and Hodgkin's Lymphoma, announced that it has entered into a Letter of Intent with The Faculty of Medicine at Khon Kaen University, Thailand to conduct clinical trials using Rich's lead molecule, RP-323 in treating AML patients. The Faculty of Medicine at Khon Kaen University has established itself as a center for world-class research. Presently, the Faculty has four Research Centers of Excellence and 23 Research Groups doing clinical research across numerous disease states with emphasis in conducting oncology clinical trials. For more information on the Faculty of Medicine, Khon Kaen University see: http://www.md.kku.ac.th/en/.

read full: http://finance.yahoo.com/news/rich-pharmaceuticals-inc-announces-letter-123500707.html
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Thu, 19 Mar 2015 13:15:00 GMT ~ Biotechnology And The Road To Innovation: What Companies Are Pushing New Innovation In Today's Market?

[Accesswire] - CORAL GABLES, FL / ACCESSWIRE / March 19, 2015 / Globally, the market for biotechnology has been growing at a rate of over 10% annually according to a report from IBISWorld. Annual revenue is on the cusp ...

read full: http://finance.yahoo.com/news/biotechnology-road-innovation-companies-pushing-131500471.html
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Mon, 16 Mar 2015 18:23:21 GMT ~ RICH PHARMACEUTICALS, INC. Files SEC form 8-K, Entry into a Material Definitive Agreement, Unregistered Sale of Equit


read full: http://biz.yahoo.com/e/150316/rcha8-k.html
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Thu, 12 Mar 2015 13:35:00 GMT ~ Rich Pharmaceuticals, Inc. Names Chittima Sirijerachai, MD as Principal Investigator for Upcoming AML Clinical Trials

[PR Newswire] - BEVERLY HILLS, Calif., March 12, 2015 /PRNewswire/ -- Rich Pharmaceuticals, Inc. (RCHA) ("Rich Pharmaceuticals" or the "Company"), a clinical-stage biotechnology company focused on developing innovative therapies in oncology, with initial concentration in treating Acute Myelocytic Leukemia (AML) and Hodgkin's Lymphoma, announced that Dr. Chittima Sirijerachai has committed to becoming a principal investigator (PI) for the upcoming AML clinical trial utilizing Rich's flagship compound RP-323. As a principal investigator, Dr. Sirijerachai will enroll patients and serve as a liaison for Rich Pharmaceuticals and supervise some of Rich's clinical study initiatives outside the United States. Dr. Sirijerachai received her Diploma in Medical Education from the University Of Wales College Of Medicine, Cardiff, England and Diplomas from the Thai Board of Hematology and Internal Medicine at the Royal College of Physician of Thailand and is currently on the Faculty of Medicine at Khon-Kaen University.

read full: http://finance.yahoo.com/news/rich-pharmaceuticals-inc-names-chittima-133500648.html
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Fri, 06 Mar 2015 21:38:32 GMT ~ RICH PHARMACEUTICALS, INC. Files SEC form 8-K, Unregistered Sale of Equity Securities


read full: http://biz.yahoo.com/e/150306/rcha8-k.html
*********************************************************



$RCHA charts

basic chart ## source: stockcharts.com



basic chart ## source: stockscores.com



big daily chart ## source: stockcharts.com



big weekly chart ## source: stockcharts.com


$RCHA company information

## source: otcmarkets.com

Link: http://www.otcmarkets.com/stock/RCHA/company-info
Ticker: $RCHA
OTC Market Place: OTCQB
CIK code: 0001504389
Company name: Rich Pharmaceuticals, Inc.
Company website: http://www.richpharmaceuticals.com
Incorporated In: NV, USA

Business Description: Rich Pharmaceuticals is a biopharmaceutical company that is focused on the development of its lead product, TPA (12-O-tetradecanoylphorbol-13-acetate), for the treatment of acute myelogenous leukemia (AML) in refractory patients. The basis for the interest of the Company to pursue clinical development of TPA in this and possibly other indications is the result of the work of Prof. Richard Chang. He has conducted research on TPA for many years and has become an expert in the characteristics of this molecule. The findings form the scientific basis for the clinical use of TPA.Less >>



$RCHA share structure

## source: otcmarkets.com

Market Value: $1,031,787 a/o Mar 23, 2015
Shares Outstanding: 859,822,675 a/o Feb 17, 2015
Float: Not Available
Authorized Shares: Not Available
Par Value: 0.001
$RCHA extra dd links

Company name: Rich Pharmaceuticals, Inc.
Company website: http://www.richpharmaceuticals.com

## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=RCHA+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=RCHA+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=RCHA+Industry

## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/RCHA/news - http://finance.yahoo.com/q/h?s=RCHA+Headlines

## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/RCHA/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/RCHA/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=RCHA+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/RCHA
DTCC (dtcc.com): http://search2.dtcc.com/?q=Rich+Pharmaceuticals%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Rich+Pharmaceuticals%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Rich+Pharmaceuticals%2C+Inc.&x=0&y=0
WHOIS (domaintools.com): http://whois.domaintools.com/http://www.richpharmaceuticals.com
Alexa (alexa.com): http://www.alexa.com/siteinfo/http://www.richpharmaceuticals.com#
Corporate website internet archive (archive.org): http://web.archive.org/web/*/http://www.richpharmaceuticals.com

## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/RCHA
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001504389&owner=exclude&count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/RCHA/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/RCHA/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=RCHA&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=RCHA
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/RCHA/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=RCHA+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=RCHA+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=RCHA
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=RCHA
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=RCHA+Cash+Flow&annual

## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/RCHA/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=RCHA+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/RCHA.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=RCHA
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/RCHA/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/RCHA/insider-transactions

## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/RCHA
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/RCHA
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/RCHA:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=RCHA
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=RCHA

[badshah]

Informative post worth in early 2015 regurgitating over...


RCHA Expects FDA Orphan Drug Fast Track Approval…

Per the CEO of RCHA below:
Quote:

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
Quote:




On Page 29…
Quote:



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:
Quote:

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:
Quote:

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:
Quote:

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:

Quote:

"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:
Quote:

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