otherwise it doesn't seem that an in-house sales force is cost effective at this time
then why did you say the Advisory Committee would be voting on June 7th or 8th? if they don't do that, will you call yourself a liar like you always do to Hakim, or will you just say they missed your goal/expectation/prediction? tim, try to understand the difference. here is your post...
Reply to Elite's Death Watch by casediagnostics •Apr 22, 2016 5:55 PM
ama0123456789 • Apr 24, 2016 3:33 AM
The Advisory Committee is voting on SequestOx on June 7 or June 8.
We will know BEFORE mid June if the FDA is going to approve it.
We aren't waiting for July 14.
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...
if so, where did you hear/read it
these are the kind of strategic moves that have lifted ELTP from .07 when Hakim arrived to where it is today
and that is what Hakim has been assembling
the folks he has brought in all have extensive experience with much bigger pharmas
they would not be coming aboard unless they believed in a great future at Elite
“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.”
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
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
everything stays the same in terms of payments, milestones, royalties, etc, -- except Elite's new partner is many times larger than Epic!
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
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
those are all extended release, and FDA is has always found it difficult to approve any ER opioid formula because of the amount of drug contained in each dose but now the FDA is also concerned about the type and amount of antagonist contained in each dose because of the potential for triggering acute withdrawal
although naloxone acts quicker and more aggressively, which is why it is used for overdoses, naltrexone also has potential for causing acute withdrawal, and it will likely be an issue when Elite files its ER doses with FDA
fortunately, ELI-200 is an immediate release rather than extended release, and should have no problems whatever with being approved. and it is good that other companies are going first with extending release formulas so that Hakim can learn from their experience
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
cased, your info is more than seven months old and the results showed only a 36 percent decrease in peak hydrocodone exposure for KP-201 when snorted
stands to reason that a snorter would just compensate by snorting more to get high
if they do that with Elite's soon to be approved abuse resistant formula they would just wind up getting more naltrexone which would, measure for measure, keep defeating their high
good luck if you choose to keep riding the kmph horse, but you are already down 25% from when those trial results got the press coverage that you are touting, while ELTP is up 50 percent
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
egalet's drug is not snort proof, it's just harder to crush
collegium's extampza has binders that affect absorption rates and are toxic to some
to the extent ELTP is down in the last month it is mostly do to Jerry selling
should get a bit of boost from FDA acceptance, and then a substantial lift from approval, with much more to come as investors realize FDA likes Elite's two-bead approach