Hakim brought a "baker;s dozen" of already approved generics to Elite from Micah, and then transferred them to Epic to produce. Epic was in the process of filing (or already had filed) CBE30 requests to FDA for approval of a chsnge in manufacturing site when six(?) of them were sent back to Elite to produce in house, and Elite then filed the CBE30's for those six
does anyone remember when the CBE30's were filed, and do we know which drugs were involved
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...
that is correct, but revenues would be increasing by more than triple digits even w/o Epic's generic
thing is, Elite is experiencing phenomenal growth and that is with just a couple of generics. Elite has many more generics that have already been approved and are just waiting for FDA to approve a CBE-30 which is a transfer of manufacturing site
but far, far more significant and valuable is Elite's pipeline of abuse resistant drugs that will address the opioid epidemic that has politicians, police, doctors, the Courts, and the FDA so concerned
as you have said many times, pps for an OTTCBB listed stock reflects market manipulation and little else until a company produces an irresistible and irrefutable product -- just such a product is SequestOx
though oxy abuse has become an epidemic, it remains the go to drug for breakthrough pain -- hence, the multi-billion market
and though no drug is resistant to oral abuse (taking too many), doctors can prescribe SequestOx confident they will not be contributing to the street market for snorting and injecting
for the most recent qtr, Elite reported over $500k profit AFTER fully covering R&D expenses
Elite might even have covered R&D from operations in the qtr being reported in two weeks
if this pattern continues, there will no need to sell any more shares to Lincoln
yep, revenues will be up by triple digits -- same as last quarter, same as they will be next quarter
read it and weep...
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."
i didn't think so
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 options are: Changing the drug class from IR to ER"
don't know what the ELI-number is, but that formulation is already one of the drugs in Elite's pipeline. Hakim will certainly give priority to moving that one through, while continuing to work on getting SequestOx approved
" the market for Oxycodone for the IR space is roughly 5.5Bn and the ER is about 6Bn"
think the number is $8 billion for immediate release, and $2.5 billion for extended release but i've seen bigger numbers for both. the IR market is waiting for its first abuse resistant entry, while the ER market already has five abuse resistant alternatives, though all have weaknesses that are limiting sales. in fact, if a good abuse resistant formulation were to enter the ER market there is good chance that market would significantly grow
bottom line is just what you have said -- notwithstanding a labeling issue that has to worked through, there is a lot of opportunity and options for Elite going forward now that FDA has blessed their patented technology
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
and the VERY GOOD news now is that after full review of everything submitted, the only issue the FDA could identify was a minor problem with the proposed label
that means FDA has agreed that Elite's two-bead technology works, and they are ready to approve SequestOx with a simple change in wording for the label
could be the last bump in this road
basically the same issue xtampza faced, e.g., when to take with respect to food
language was put into xtampza's label instructing that it be taken with food...
"• Instruct patients to take XTAMPZA ER capsules with food in order to ensure consistent plasma levels are achieved."
in the case of SequestOx, the label would instruct patients to sprinkle on food, or take before eating
Manufacturing and Supply Agreement . ELITE shall supply Product to EPIC at cost plus ten percent (10%) and the parties agree to execute a separate Manufacturing and Supply Agreement (the “Manufacturing Agreement”)."
upon approval, SequestOx will become the only immediate release abuse resistant formula in the multi-billion oxy market
and though oxy abuse has become an epidemic, it remains the go to drug for breakthrough pain -- hence, the multi-billion market
and though no drug is currently resistant to oral abuse (taking too many), doctors can prescribe SequestOx confident they will not be contributing to the street market for snorting and injecting
what makes it especially great is that SequestOx is just the first of an abuse resistant line using the same technology. once FDA approves SequestOx it will be a green light for the rest of the pipeline