READ THIS POST!!!!!
I spoke to Dianne this morning for about an hour, and got multiple questions answered. Some were questions that I had, and others were questions that I see being thrown up on the message boards. Alright, let's get started....
1. The clinical trials that were expected to have began middle of March / beginning of April are still on track. There is nothing wrong with any of their drug formulations, or a lack of money to start the trials. They are delayed slightly due to Elite not receiving the results from the past two trials as soon as Nasrat had thought they would receive them. They needed to have those results in hand before they could file the appropriate paperwork and trials could commence. So everything is A-Okay in that department. The trials will be starting soon.
2. They will be filing at least one NDA with the FDA this year. The first product they will be filing is their ELI-200, which we were recently informed on the great pivotal trial results. When I say at least one, that is because they hope to file more. This is not contingent on Elite having a partner. They are going to do this with or without one.
3. Nasrat expects to have their first ART opioid product on the market, bringing in revenues, by August of next year. He is hoping to launch more than one product next year.
4. Isradipine is expected to have the site transfer approved in the next few weeks, and launch shortly thereafter. They do not expect any delays. Epic is still expected to file the next three generic drugs in June/July. Elite expects to see revenues from those drugs in July/August/September. These four drugs, and their multiple formulations are the four largest money makers of the twelve Mikah generics.
5. The poison pill was put in to place after one of the potential partners they have been talking with basically stated that if Elite wouldn't take their offer, they would just buy the company out from under them on the open market. This company wanted "the whole thing".
6. Our new hire, Barbara, will be responsible for all of the filings with the FDA. She was brought on by Nasrat due to the fact that she is a well seasoned expert in this area. She knows how to get these drugs though the approval process as quickly as possible.
7. They are still in talks with multiple partners. There is no waiting period associated with the proxy vote to raise the A/S. They could sign with a partner any day.
8. They have no plans of merging with EPIC. EPIC has no interest in being a publicly traded company. We can stop talking about that now. It's not going to happen.
9. The proxy vote will be going out in the next week, as soon as tomorrow. It is very important that everyone votes, and a yes vote would be beneficial to all shareholders. Dianne told me that all of the "insiders" will be voting yes. She explained that a no vote would not be good for multiple reasons. First off, there would not be enough common shares to cover Jerry or Nasrat's preferred shares. Second, and in my opinion more importantly, without the approval of the A/S raise, Elite has no fall back option when negotiating a fair deal with a big pharma partner. Don't get me wrong here. Dianne told me that a deal could be struck any day, but one of the things that has been holding it up, is the lack of options for Elite. Nasrat feels that if we get further along in the process of developing these drugs, coupled with the option to fully go it alone, that we will get a much better deal with whichever company ultimately partners with us. Elite is "on the cusp of doing something big", Dianne stated to me. Voting no for the A/S raise would pretty much guarantee that we will either have to go it alone, one drug at a time, or take a not so great partnering deal. I will be voting yes, and I encourage everyone here that want to maximize their investment returns to do so as well.
10. Nasrat and Barbara both feel that once we get an NDA approval for our first ART opioid, that all subsequent ART opioid approvals should go quicker/easier. Elite will be using the same CRO (Clinical Research Organization) for all of the drug trials. It's kind of like once you spend the time sighting in your rifle, you can just keep hitting the bull$eye.
11. Nasrat was surprised on how quickly the stock ran to .97. He viewed it as a momentum run. The fact that the stock price has pulled back since then, has nothing to do with what is going on at Elite. They are further along, and in better shape today then they were when the stock was trading in the .90's. He believes the true value of what we have will be recognized sooner than later. He expects to bring in around $500,000,000 annually from ELI-200 alone.
12. A R/S would only be considered if they had really big news ie.....NDA approval, garnering good revenues from ELI-200, etc. There is no plan for a R/S as of now. Dianne also stated that if they did a R/S in the future, it would most likely be coupled with an uplisting, and probably have both details in the same PR. It would only be considered from a position of strength. Dianne stated that Nasrat would want the stock price to be over a dollar before even considering it.
13. Dianne herself is an investor in Elite. She currently owns shares, and is excited for the future. She is thrilled to have the excellent management team that we have. She believes that Nasrat is exactly what Elite needed to get these drugs to market. I share her sentiments.
So.......a general synopsis. All is well with Elite. We are on track, and moving forward. At least one NDA with our ART tech will be filed this year (ELI-200), and is expected to hit the market by August of next year. Anyone that wants to see Elite hit a homerun with their ART drugs should vote yes for the A/S raise. I did last time, and I will be this time as well. I urge all of you to follow suit. Good luck everyone.
AI
