he's been here three years and has never sold a share or taken a penny in salary
clearly, he is holding for better days
he has also bought shares on the open market and put them in a trust fund
Hakim was given rights to those shares when he took over in August of 2013 -- he had three years to either convert the rights into shares (at the then current price of .07 per share) or receive $10 million cash. he opted to convert into equivalent preferred shares in February (i think) of 2014. not sure why he didn't just take the common then, but it looks like he still had to convert into common on the third anniversary of him taking over
those rights supposedly represented payment for the 'baker's dozen' of drugs Hakim brought with him from Mikah but i suspect it was also, in part, a signing bonus
"As of June 30, 2016, the Company had cash on hand of $12,814,951 and a working capital surplus of $13,607,755. We believe that such resources, combined with the Company’s access to the remaining $18.1 million available pursuant to the $40 million equity line with Lincoln Park is sufficient to fund operations through the current operating cycle."
last quarter, Elite reported over $500k profit AFTER fully covering R&D expenses
Elite might even cover R&D from operations in the quarter being reported this week
if this pattern continues, there will no need to sell any more shares to Lincoln
reminds me of a senior friend who once called asking for my number because he couldn't find it
anyhow, try cutting and pasting this, then book mark it a few times because it doesn't always work, and then share it with folks whom you haven't been seeing on the board and would like to...
have to think the request for a meeting has already been made, and should be held by end of August at the latest is FDA follows its guidelines for NDA's that have received CRL's...
"Type A meetings should be scheduled to occur within 30 days of FDA receipt of a written meeting request."
FDA was briefed on all the results of studies done in support of SequestOx, including this Tmax issue, when Elite met with them in November and answered all questions. FDA subsequently accepted SequestOx for review and asked only for a labeling study rather than another BE trial to address the Tmax/food issue
the results of the labeling study simply confirmed what FDA already knew in November, e.g., that taking with food needed to be addressed on the label. again, that was already understood by all parties
but the Complete Response Letter completely ignored that understanding, and the FDA is acting as if the issue is all news to them. if Hakim sounded a bit upset on the conference call, that is why
well, unless FDA's SequestOx reviewer was not aware of the November meeting, or was reassigned and not involved in writing the CRL, FDA has some explaining to do when Hakim next meets with them
and, that is why you should consider contacting your rep in Congress and letting them know the FDA is holding up an abuse resistant immediate release oxy that has no value as an illegal street drug
the FDA response to an NDA is a COMPLETE response letter, which means they have reviewed everything submitted up, down, front, back, upside down and inside out, and they are telling the applicant absolutely everything that stands in the way of approval
and the ONLY concern the FDA identified was a minor issue involved a labeling issue which has been routinely addressed for many, many other drugs by simply adding instructions to the label explaining whether to take the drug with or without food
no big deal, just a temporary delay, another bump in the road that can be expected though not predicted when dealing with the FDA, and SequestOx will
HOWEVER, there is something of great significance to shareholders contained in FDA's response because FDA has in fact confirmed not only that SequestOx can be approved but that all of Elite's pipeline using the same two-bead approach will also receive approval
just consider what has happened -- FDA performed a complete, inclusive, comprehensive review of SequestOx, and could find NO problem whatever with any aspect of Elite's two-bead pharmacological ABUSE RESISTANT technology. yes, FDA accepted the Human Liability Studies along with the safety and efficacy studies. in fact, if SequestOx had been an Extended Release (the formulation for which is already in Elite's pipeline) instead of an Immediate Release it would already be approved
folks, this is huge! the FDA has confirmed Elite's technology by NOT identifying it as an issue in their Complete Response Letter. and that means Hakim is right -- nothing can stop us. there may be a few bumps to get over and potholes to get around, but nothing can stop us
every situation is different and there are no controlling regulations. the CRL gave Elite one year to respond but Hakim will certainly move as quickly as possible to meet with FDA and determine best path forward
conference call coming up in three weeks. send questions to Dianne for the Q&A portion. if you do it now, it's possible you get a personalized response before the CC, but probably not
don't know if you listened to the call on Monday, but two things stood out. first, that Hakim sounded both angry and anxious -- angry that FDA had not told him about their concern at the November meeting, and anxious to get off the call, get to work, and get this resolved
second, that Elite has never been more assured of success than now. why? because while this is a temporary setback for SequestOx, going through this process has confirmed that FDA has no problem with Elite's two-bead pharmacological approach (had SequestOx been an extended release rather than immediate release it would have been approved), and Elite is in its best financial shape ever -- easily good enough to be submitting another NDA each quarter through the end of 2017, especially since revenues are growing at a triple digit pace such that Elite actually turned a profit last quarter even after fully funding R&D
prior to 2008 the FDA would have issued an "Approvable" letter for SequestOx and explained in the letter what needed to be done to get approval