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The in vivo studies include bioequivalence and bioavailability fed and fasted studies comparing the modified formulation to the original formulation. Did someone mention this also involves the polymer's thickness or density
Let's get this party started. Big day for elite today
Dah, why wouldn't Pfizer launch sooner or later and whoever buys Elite will make the money later but that will be built into the buyout price
PH4: AGREE; MAYBE NEW PR TOMORROW - SOMEONE KNOWS SOMETHING.................GOOD!!!!!!
my scttrd acct showing 600,000 on the BID and 1,000 on the ASK
I AGREE CAMELMAN; SOMETHING ELSE IS WORKING BEHIND THIS PR - COULD HAVE RELEASED LATER IN WEEK; WHY MONDAY...........NOT ALL OF NAS's cards are on the table YET
COOL 2010; may have to re-file the request after they have it published
Possibly Trump will be the best thing only though because he wants to be able to claim it was him that got the technology of the future of elite approved in to the market a feather in his Something else to talk about don't care just as long as it gets it done
Excellent 2020 just excellent thank you
I meant happy birthday on July 17 but you could start now never too early enjoy every day it's going to be a great great great year for all of us longs holding ELTP
HAPPY B-DAY DARLIN'
Realistic: MUST be OF BENEFIT TO BOTH PARTIES INVOLVED!!!
my logic on buyout mid 2017 the BUYER won't wait to UP THEIR BID PRICE as WE GAIN POSITIVE, UNSTOPPABLE POTENTIAL THEY WILL OFFER A FAIR PPS FOR BOTH SIDES
IMO: I say 1.5 to 2.5 BILLION BUYOUT BY JULY, 17, 2017 !!!!!!!!!
Bigguy: AGREE = IMO Elite has been on humanwell/puracap's radar FOR YEARS; the Epic deal LET THE CAT OUT OF THE BAG AS THEIR PRIOR MERGERS WENT UN-NOTICED! I say 1.5 to 2.5 BILLION BUYOUT BY JULY, 17, 2017!!!!!!!!!
Going to be a very green day today get in now or you will be chasing it forever you have been warned
End of January update from the FDA and additional comments from elite about the future approval along with this to look forward to in 2017 :
"We are extremely pleased that there is a path forward to seek FDA approval of SequestOx™," said Nasrat Hakim, President and CEO of Elite. "Based on the guidance received from the agency, Elite will begin to execute the proposed plan immediately."
2017 is definitely going to be our big year. My PPS prediction is by July 1, 2017 without any reverse split without any dilution PPS will be above $1.50 a share
You got it JR right on the money 28 to 33 around third week of January waiting for game plan announcement by the FDA and at the same time elite going to be big If it's very positive could break the 45 mark the week after announcement and higher
WOW; 366'000 ON THE BID
YES IN DEED Turnaround; b4 crl no FDA PUBLIC INPUT NOW GIVING FINAL INSTRUCTIONS FOR APPROVAL THIS SHOULD BE BACK, AT LEAST, TO .35 - .40 AND PROBABLY MUCH HIGHER WITH M&A LOOKING ON!!!!!
SOON, REAL, REAL SOON BIG PAYDAY $$$$$$$$$$$$$$$$$$$$$$$$$
Clear path did I hear clear pathway to the approval Finishline I think so
Called at 4 o'clock spoke with elite personnel said they are open running normal very few people have the week off
Confidential Treatment” and addressed to The Secretary, Securities and Exchange Commission, Washington, DC 20549
Court ordered confidential treatment CT
I really believe the terminology clear path was used on purpose and has substantial meaning
Nobody mentioned the court order also issued on 12.22 interesting check the S EC filings
A special holiday thank you to Nas and his group of talented professionals as investors we are grateful to have you and what you're about to bring to the general public is a fantastic gift for all
Merry Christmas happy holidays to all and we are guaranteed a fantastic 2017 well worth the wait
Trying to find documentation on meeting minutes and timeframe for distribution
Merry Christmas shark no way too simple for the government FDA is in big farms pocket this was a way to delay it something else going on somewhere and just show how they dominate and control everything and yes it actually does need to be in place and I guess there was some reason they could not supplement and be told during the process but that's the government for you hopefully I think that is all it is simple This post approval stipulation was not in place throughout our process you would think they would be given the opportunity to supplement during the process but once again FDA is FDA hope that's it we should be rocking and rolling real soon very early 2017 we will know real soon baby merry Christmas to all longs
I forgot to mention the completion of this new FDA post approval approval - Analysis process would definitely be a safety issue which is what they referenced in the CRL but in my opinion not much of one to two assuming there will be no issues but the process must be in place and I think that's what they were missing due to not being told they needed it
i'm interested to see in January if all of this delay was due to the following from the FDA's own report :
All of the companies that have approved brand name opioids with AD properties reflected in their labeling are being required to conduct postmarket studies to determine the impact that AD technologies are having in practice. Having that information is critical, and will allow us to take the next important steps in this area.
I don't think we had a post marketing plan in effect due to when we originally submitted this that was not a requirement which if you read the FDA statement it is now a requirement ! If this has been hit it should be relatively easy and I'm sure that's what they're working on
NOTICE THE WORDING: Based on the FDA response, the Company believes there is a clear path forward to address the issues cited in the July 14th Complete Response Letter ("CRL"). The FDA will provide minutes of the meeting by the end of January and the Company will issue a further update at that time.
"CLEAR" path NOT JUST a path; I THINK THIS SIGNALS A MEETING OF THE MINDS IN A RESOLUTION TO APPROVAL!!!!!
Nope; I also use Scotttrade. they do really strange things premarket! ; Like bid at .0001 ask .41 ! Zero and zero means nothing NOW but if it stays like that at opening then yes, but it won't
Thanks Fuzz
The statement from the CEO was a meeting with the FDA the third week of the December with no specific dates
We are not sure what was meant by the third week
It was said the third week of the December no specific dates
Yeah baby were back up man that was weird looking forward to a great week
Good stuff 2K