everything stays the same in terms of payments, milestones, royalties, etc, -- except Elite's new partner is many times larger than Epic!
FDA had already reviewed the HAL and BE studies for SequestOx and only required a smallscale, quick Phases III efficacy trial and a labeling(!) study prior to filing
FDA has since given priority status to SequestOx and waived off having an advisory committee to help them make their decision
'nuff said...approval could well come before Bastille Day
tim, Hakim has brought in top talent that is above and beyond what a little pharma, let alone a scam, would be able to do
these folks did not join up to ruin their careers -- they see huge potential, and so should you
also, Narine did not issue himself shares. he was owed those shares, and the price was set long ago. you should not begrudge a person for accepting his due. suspect the new Director will be similarly compensated because most folks who do work expect to be paid in some fashion...
that's year over year for the 4th quarter, based entirely on generics
imagine what next year's 4th quarter is going to look like with SequestOx in the mix...
that is why doctors everywhere will be prescribing it
just consider that Elite and Epic shared a CFO
yep, that's Carter Ward
he joined Elite with the understanding that he could continue with Epic part-time
and during that period he arranged for Epic to fund Elite through its most difficult period
yes, that's right, Epic funded Elite in its most desperate times and Elite is alive today because of it
as a result, Epic's founders collectively became Elite's largest shareholder, and Hakim has known them well for a long time
then we have isradipine which Hakim sent over to Elite to manufacture and distribute until Epic found out that they didn't have the right equipment to produce the stuff -- Hakim just took it back to produce in Elite's facility and is still letting Epic distribute
these companies have been virtually joined at the hip for years, and Epic's management has much to gain by keeping that relationship going and growing under the auspices of their new, rapidly expanding, international parent
collegium is taking the gummy approach using wax and fatty acids which, as reported, have potential to either interfere with intended release of the drug and may not provide solvent abuse resistance -- and which pose health risks
many of us have been defending Linda's silence given that anything she has said was quickly twisted into a negative but, at this point, what's the difference? there is no need to fear the effects of misinterpretation anymore
just consider it has been almost two years since the German Hospital Exemption and still there are no stories about non-German, self paying patients being treated. or the fact there were already 66 events in December of 2013, and that the first interim analysis would likely be done in February two years ago
so really, what is going on with PIMS, capacity expansion, Canada, phase I/II unblinded Direct trials, the screening suspension, or anything?
and will likely at least double year over year in the quarter ended March 31st
i had trouble using links that were suggested, but this should take you directly there
it is all about the Northwest's L-vaccine
for those who say Northwest isn't mentioned, zero in on the 8:00 and 32:00 minute marks
for those who are questiioning mention of a partnership, go to the 20:00 minute mark where Prins clearly says Merck and Bristol Meyer are partnering with DC-Vax in trials to start soon
and possible announcement on second filing
the Human Abuse Liability (HAL) studies, which FDA reviewed prior to formal filing, demonstrated that ELI-200 cover both snorting and injecting -- which is why FDA did not require any additional HAL studies
basically, no solvent tested could dissolve the oxy, leave behind the naltrexone, and yield something that could be injected
ELI-200 releases oxy in the presence of very strong acid, and before someone would do the work of neutralizing the acid and somehow sorting the oxy from the salts that would remain it sure seems they would just go looking for some heroin
ELTP has outperformed coll over one month, three months, six months, and nine months, so you can stop wondering why coll is up...
also it is very true that FDA is concerned about adverse effects and consistent efficacy with xtampza which is why they delayed their review
regardless, it seems we agree that great emphasis is now being placed on preventable drug abuse, that the abuse resistant market will be huge, and that Elite will be right there competing for a share of what promises to be a big pie
good chance you are right
regardless, very much looking forward to the June earnings report and CC
and, can you believe the Team and the Board that Hakim has put together -- wow!
“PuraCap wants in on the opioid market, and Elite's proprietary technology and its licensing deal with Epic was their way of gaining that access.”
well, it's never gone back to .21 and timtim has been gnashing teeth and clenching fists ever since
and every time someone brings up this little truth, timtim screams liar
looking at a record 4th quarter and a record year when earnings are announced in June
already have positive cash flow but with these huge increases, Hakim will even be able to cover more and more of the R&D until SequestOx hits the market and then it will be Fat City
and Hakim has a pipeline of drugs using the same abuse resistant technology
Elite is poised to experience explosive growth beginning with approval of SequestOx
perhaps the biggest problem with xtampza is that it can be abused simply by chewing which is not the case with ELI-200
bottom line is that ELI-200 will be prescribed by doctors because it will not be used by those who are looking to abuse when it cannot be snorted, injected, or chewed to achieve a satisfactory high, and the cost of taking a whole bunch at one time will just be too expensive for an abuser to justify
the FDA 'liked' that they were trying to develop an abuse resistant drug -- just as the FDA likes that Elite has developed abuse resistant ELI-200
unfortunately, when the FDA realized collegium was using wax and fatty acids as binders in its gummy bear formula, it was cause to pause for the FDA and that is why their PDUFA date has come and gone, e.g., collegium has been put on the 'maybe we need to require some more trials' path