Team Long - After many hours of research, I believe I have cracked the code on WHO the FlutiCare ANDA original applicant and manufacturer is? I have been putting the pieces of the puzzle together and finally, it was right there in front of me. Team I am about 99% certain this IS the company the good Dr. Damaj partnered with to get his FlutiCare approved by the FDA. He wanted a company with a stellar record and major status to go head-to-head with GSK or Bayer in case they rattled their sabers to protect their billion dollar allergic rhinitis (nasal spray) market. He INSISTED at the time of the Novalere filing that THIS company has to be the ANDA applicant and the manufacturer when the OTC is approved by the FDA.
Do you guys want to know the name?
Now that I believe I know who the manufacturer is (a real power-house), I will be adding shares on Monday. I am not boasting; just sharing how confident I am FlutiCare will get approved. Actually, I am not even worried about FlutiCare; I am now focused on 2017 profitability and up-listing in 2018 so we can see some "real" growth in shareholder value . Team - As we know well, it is important for Innovus to hit the two immediate milestones in order for it to have a decent shot at up-listing. The first milestone is FlutiCare approval and the second material event is NOI profitability at the end of 2017. In my opinion, these are the two major events that we need which will help start the SP assent.
With respect to FlutiCare approval, Innvous needed a "heavyweight" pharma manufacturer to file for the ANDA so that it could have reasonable chance of FDA approval. Not that this is be-all/end-all, it just means the road to approval was being given better odds of success.
Here is how I deduced the name of the pharma company:
I have gone back and looked at several interviews Dr. Damaj gave since 2015. I was looking for any clues he may have shared. I was particularly interested in his October 2016 interview and looked at a couple of sections very carefully. In this interview, he said that he was very clear in his filing (with Novalere) that the ANDA application MUST be filed by this one particular company who was the holder of the (Fluticasone Propionate) Rx ANDA and also the manufacturer of the Rx. This was a huge clue and so I focused-in on this statement.
I then looked at some of the information/profile I had gathered previously about the original ANDA applicant. As I shared with you all last week in a posting, the original applicant is a major player with revenues of over $1 billion and well over 100 FDA approved products on the market and has manufacturing plants in the U.S. as well as overseas. I verified this information with IR so I knew we were on solid footing. While IR never gave me the name (they obviously can't) but did confirm that this major pharma company already had an FDA approved nasal spray on the market.
So I did some more digging:
I looked at all the Fluticasone Propionate (nasal spray applications) approved by the FDA since 2004. I wanted to look for a company that was the holder of the fluticasone propionate Rx ANDA and was also the manufacturer.
And that's when I came across ANDA # 076504 which was filed by West-Ward Pharmaceutical and approved May 14, 2004. I believe this was the "hint" Dr. Damaj shared in his 10/16 interview.
So team, my conclusion is that Dr. Damaj partnered with Hikma Pharmaceutical when he transacted with Novalere. Hikma is the parent company that will produce our FlutiCare through West-Ward which is a holly-owned subsidiary of Hikma based in the U.S. To me this is conclusive because last year, West-Ward Pharma partnered with Perrigo Company plc (a leading supplier of OTC products) to market and sell fluticasone propionate as an OTC product which was approved on 5/31/16.
Go and check-out Hikma Pharmaceutical and you will see how Dr. Damaj could have ties with this company given that this is company has deep roots in Jordan and Dubai. Hikma did about $1.3 billion in 2015 revenue and has manufacturing plants in the U.S. and many other countries and all are FDA approved.
Team - I may be wrong about this but at least we know that FlutiCare is in good hands if I am correct with my due diligence. If FlutiCare gets approved, NOI profitability will be inevitable followed by increased shareholder value followed by up-listing etc. Please remember Hikma got fluticasone propionate approved for Perrigo on 5/31/16 which means the FDA will probably approve their second fluticasone propionate (FlutiCare) by May 2017 or thereabouts. Just a hunch.
Nice opinion .......research.
AI
