DavidAllens CC notes: plus a few more
3 studies - 2 for label informational only, then efficacy
label - food or no food, information only
label study withdrawal study - not pass fail, but for info only
efficacy study - FDA WILL answer us in middle of March
5 sites are ready and recruited 150 patients , and just need FDA go ahead
8 weeks from middle of March study to complete
after that target date and data analysis still plan to file in Q3
FDA may wave Efficacy or possibly a smaller group
FDA notified elite late and hence the delay from the Dec filing, this was not due to Elite in anyway, just the overall FDA process introduced the delay and new path
Facility is being scaled appropriately and on track
Caller questions and shor thand answers (not quotes but trying to be accurate as possible)
1) only 150 study, why is this so small in numbers? Is this just a box checking exercise
-Mr Hakim - Yes this is viewed as a just check the box, and that FDA has enough info on naletrozone and such that the requiremetns are becoming more reasonable.
Seems like no technical concern on passing the phase Elite will know what the FDA wants theother ones will go much faster.
After first ADT approval
2)will there be another evaluation of company worth?
Mr Hakim - This will happen next year as we head to Nasdaq. Fundametals will drive the shares, the stock will take care of itself is my opinion, we are doing all the right things
previous study was done part of the share holder rights
3) Now that there are set parameters for eli-200? Do we now know what is needed for 201 and 203
Mr Hakim - Yes we know more, it will be more expensive but yes we now how this needs to go forward
4) Fast track approval I am hearing, does this mean it will get expedited review?
Mr Hakin - FDA has told us in writing that we qualify for expeditied review. So if we file in Q3 we will be approved in 6 to 8 months.
5) NASDAQ pps and how to get to NASDAQ, what is plan to elevate the pps to get there?
Mr Hakim - multiple ways
organically - thru fundamentals, products and revenues. pipeline, introduce 1 product
reverse split - not making any decision now, until we here fromt he studies for eli-200
2016 for uplisting
6) can you clarifiy the PZE ALO-02 product and eli-201, major differences?
Mr Hakim - the difference is that theirs is 1 bead our is 2. I do not know if they fixed the leakage(leaked naltrexone), assume they did but not sure. Our product did not have this issue, other then that the 2 are very similar
Elites tech is much better at sequestering Naltrexone
7)How do you see Elite gaining market share in opiod market
Mr Hakin - room for everyone in 8 billion market. IF elite can get a portion it is good. PZE is leading and creating the market as they are paving the way for elite to get into that market. When a company like PZE has similar technology and taking it forward it will make elite more attractive as the tech is right.
8)cost of phase 3?
Mr Hakim - our current trial will ba about 4 million dollars for just the pahse 3, the other 2 will add 3 or so. total 7-8 million which we already have to cover. I run the company like I do my own finances. So we are prepared and we can get this to finish
money already in the elite bank for this
9) are you feeling elite is beign strung out to dry being a small company by FDa
Mr hakim - I do not want ot say antying bad about FDA. this is America and we are happy with FDA and we are going to launch this first of as series of products over the next few years
10) timeline for the undisclosed from 3 years ago
mr Hakim - need to follow up on it, not that great of income generating product, and will try to se ewhy it is taking the FDA so long to respond.
10 billion dollar pain market
We will partner with someone to compete with Pfizer(X2)
Pfizer's will get the market ready for Elite to step in.
retired some bonds getting fundamentals ready NASDAQ
infastructured in place for adt launch 1.5 million spent on facility expansion , upgraded equipment in last year
support produt launch
Partnering
ELI-200 solid formulation
Upward trend in revenues continues Generic sales up 24%% no milestone this quarter
strongest balance sheet ever
Hydrox and Dantoline nearing launch near term
continued optimistic outlook
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