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:
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:
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:
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:
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:
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: