Rich Pharmaceuticals Inc. (fka RCHA)

[sunspotter]

When people discuss likely biopharma penny stock scams such as RCHA, they're often very cavalier with words when they discuss the likelihood of "FDA approval".

In the case of RCHA I believe it's used in several different ways which serve to confuse and give the uninformed investor more hope than they should have.

To be clear, people bandy the term "FDA approval" about in three ways when discussing RCHA and similar scams.

The first is not an approval at all, really - it's the failure of FDA to object to an IND filing. These are lodged with FDA before a clinical trial program can commence in the US - without one, drug product can't be imported and trials cannot be conducted.

If FDA don't object or ask for further discussions within 30 days after submission, the IND is considered "approved":

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm071098.htm

In the case of RCHA, it's interesting that they claim to have submitted an IND over fourteen moths ago:

"Rich Pharmaceuticals submitted an investigational new drug (IND) application in October 2014"

http://ih.advfn.com/p.php?pid=nmona&article=65739302

and yet have only recently PR'ed its approval - more than a year later.

That can mean only one of two things - either they lied about when they submitted it, or they have had serious push-back from FDA. (It's also interesting that they announced a nobody in an obscure hospital in an obscure country as their "Principal" Investigator, but let that pass for now.)

Secondly, getting designated as an orphan drug is also sometimes mislabelled as "FDA approval" (and not by accident, it should be added). Gaining such a designation says little or nothing about the merits of the drug being discussed, it simply means that the product is being developed for a disease that affects a small percentage of the population. As I have posted already, only around 12% of drugs designated as orphan drugs ultimately gain FDA approval:

"2,979 drug-indications were listed in the FDA database representing 2,200 unique drugs. 365 of these drugs received marketing authorisation between 1983 and 2013. 266 drugs were withdrawn from the list. Nine drugs had an approval date earlier than designation date, and were therefore also excluded." •

www.rare-diseases.eu/wp-content/uploads/2013/08/151_t5.pdf

365 approvals out of 2979 represents exactly 12.25%.

Thirdly, there's what most people would mean by FDA approval, the granting of a New Drug Approval, or NDA, which allows the product to be launched and promoted in the US.

That's what the promoters of RCHA would like people to think is imminent for RCHA's drug.

Nothing could be further from the truth.

To gain such approval, even in a orphan indication, will take several years, cost hundreds of millions of dollars, and is likely to fail anyway (the failure rate for new IND programs is around 80%: http://www.sponser.co.il/ForumFiles/ac3eec8f-d0af-42df-87b6-cfcac6e60af5.pdf).

As RCHA apparently can't even finance its existing operations without gaining toxic finance for tens of thousands of dollars, it clearly will never have the resources to conduct a full clinical program for its alleged drug candidate. After all, it doesn't even have an IND yet, so can't even start this multi-year program costing at least $250 million.

In reality, a minimum of proper DD for RCHA shows it is almost certainly a stock-selling scam, and definitely not something that anyone should ever consider gambling on