Nasrat put these to bed: (removed last line that may have got post removed as off-topic)
1) need for phase 3, which is to show efficacy and perceived ELTP delays in starting, current status, future timeline, expedited review:
-Our consultants were not expecting the FDA to ask for this efficacy trial when we got the news in December. (Not ELTP caused delay)
-protocols and drug need to make it to the trial sites in advance of recruiting. This FDA review and approval led to additional time.
-Trial has indeed started, surgeries have taken place
-He expects based on the current 5 trials sites, current enrollment trajectory with surgery schedule to wrap up in 6 weeks.
-ELTP WILL be ready with the equipment and process to manufacture ELI-200 by the end of calendar 2015 in prep for NDA approval
-FDA has given written letter to show expedited NDA review
-expects sales to start calendar q2 2016, with revenue making it into the calendar q3 2016 (fiscal 2017)
-the market for ELI-200 is in the 9 figures (xxx,xxx,xxx), and they anticipate that ELI-200 will get decent share of that
2) EPIC deal vs other companies
-They were big companies that tried to gobble up ELTP and their IP for little to nothing. Some may have had larger down payment, but they want to own the IP and world wide rights as well. Nasrat was not having any of that....
-EPIC allowed ELTP to write the contract, he said it is a Win Win for both companies (royalty % not released). Believes this sets them up for the fundamental growth required to get up listed, and also may lead to future offers
So if the deal is bad, then ELTP has no one to blame but themselves (I personally trust they did the best they could do for the company and share holders in this deal, and future planning)
3)eli-201 studies
-All test and data is just great and fine. ELTP had to submit in writing a letter to go over the dumping data, and the FDA agreed it is not an issue with ELTP tech or drug, ELTP just waiting for FDA to now acknowledge and respond to what was submitted. There is no issue to be worried about tech or drug wise
4) ELTP IP
Nasrat believes the platform is a billion dollar platform
5)Future communication
Do not expect any future communication until the ELI-200 done, all focus is on that. (some will try to show lack of communication in a bad manner going forward, but Nasrat spoke directly to not expect anything until ELI-200 phase 3 is done.)
6)Perceived date slips and perceived lack of communication
-Nasrat was a little upset at this questions and his response was:
We did more in the last 2 years then companies do in 5-10 years, and that in the pharma business delays will occur. (note that ELTP was not why thigns would get delayed, they got additional requests from FDA that they must deal with and will continue to support the FDA requests).
Felt they have communicated what is happening and they delays as they occurred
7) Generics are still being worked
-Why some items went to Epic was to allow them to proceed and still have the ELI-200 and other progress to fruition. Strategic plan to allow the company to progress on all fronts.....
8) EPIC no longer holds any ELTP shares, and EPIC revenues were over 120 million
9) Future ELI products based on ELI-200 work to date
-Thinks that some of the formulations will benefit from the eli-200 and other trials to date, so there may not be a need to do HAL or phase 3 again, however other formulations are different enough where it is expected to have to do HAL/pahse 3 for them.
-Everything we have done counts towards something
10) Need fundamentals to drive NASDAQ uplisting
-Thinks the EPIC deal is the start and organic growth is getting us there
11) Stock price
-Nothing to do with the company performance, the fundamentals are going in the right direction and the stock price will follow
-no comment to the shorting or manipulation question.
IN SUMMARY BASICALLY EVYTHING THEY HAVE SET OUT TO DO IS OCCURING (maybe a little delayed), BUT IT IS HAPPENING. HOLD ON, THIS WILL BE FUN!!!!!!!!!!!
AI
