FDA and Nasrat have been working harmoniously on SOX
That would be the hope and expectation. However, we should recognize that Elite has an expanded set of market opportunities. Clearly SOX would be a great addition, but let's be clear that the other opportunities actually offer greater monetary potential.
So, if I amend the portfolio offered by Nasdaq2020 to show the opportunities that do not rely on resolving the CRL for SOX or contending with a Purdue lawsuit for generic OxyContin, here is what investors should see that suggests a more substantial opportunity than merely the approval of SOX...
Elites 2018-2019 LineUp:
A. SunGen ANDA #2- $1.6 Billion dollar market with one Name Brand and 3 generic competitors. FDA filed and under review. Approval in 10-12 months
Quote Nasrat: “The last ANDA that was filed in May was an extended-release CNS stimulant that we co-developed with our partner SunGen. The branded and generic sales of this product are approximately $1.6 BILLION and there are currently just FOUR manufacturers which includes the branded and its authorized generics.“
B. SunGen ANDA #3 GODZILLA Bigger than SunGen #2 greater than $1.6 Billion Market unknown number of competitors at this time.
Quote Nasrat : “We have another product (SunGen ANDA #3) that we're partnering with SunGen, that’s bigger than this one (SunGen ANDA #2).”
C. Unique Novel ADF THE GOLIATH (new technology) which is 90% cheaper than the competitions
Quote Nasrat: on new ADF platform “I am extremely excited about this formulation because it is also a platform that applies to all the IRs and its about 10% of the cost. So we're extremely excited about this, but it's still early, in the next few months once Dr. Smith files a patent and we do a few more trials, we’ll update everyone more about it. “
D. Isradipine THE WILDCARD : Approved and Launched Positive Isradipine-Parkinson PH III Study 1 competitor 1 million patients. Third party study nearly completed.
Investors have to be energized by the transition of Elite from the one trick pony that was a SOX approval, to a pharma business that has a strong portfolio of products. And, increasing revenues. On that point, it is possible if not likely that Elite could become CFP in the 2019 calendar year. I said CALENDAR YEAR.
It’s not been very harmonious or very often. More like long and drawn out and very vague. Remember expedited review. Interestingly I’d hate to see how long it would take not being expedited. Only been about 33 months since they filed and still no clear pathways forward. But hey at least now they have unlimited pathways forward. They just don’t have enough money time or resources to pursuit them all.