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10K will be filed prior to CT expiration.
Yes, and similar to Elite, TTNP had priority review based on a plan approved by the FDA and it got rejected. Took them 2 years to resubmit and are still waiting from FDA. They have tech that avoids the oral abuse of buprenorphine since it's a subdermal implant, but for a very specific abuse population.
Priority Review - 6 months from submission. Regardless, less than 4 months to go assuming FDA meets their guidelines.
I completely agree. I'm looking forward to the review in anticipation of an approval that will bring forth a slew of other products over the next couple of years.
Fast Track & Priority Review are not the same.
Because why would anyone in their right mind think favorably of a stock/company on verge of revolutionizing ADF market or a company that is on the verge of a treadmill portfolio rollout with a value of several billion dollars? Beats me.
From my understanding, the review date is normal for priority review as it is 6 months from the submission date of Jan 14th. Up 13% today out of the gate. The stock will continue to get more and more visibility for the next few months. Less than 4 months to go until an FDA decision, if not sooner.
If you have nothing to hide, why worry? It's like going through security at the airport - for the betterment of all those participating in travel or in this case paying taxes. It's also similar to Medicare/Medicaid when these programs are being abused at egregious levels. Having some form of audit or checks/balance in place would ensure the programs effectiveness.
FDA concerns about oral abuse with abuse deterrent opiates. Purdue adds some interesting points. Very interesting.
http://www.businessinsider.com/robert-califf-abuse-deterrent-drugs-have-a-big-flaw-2016-3
Saying Elite's product us unabusable is 100% inaccurate. Please stick to the facts. We have enough unwarranted hype here.
Unabusable as in can't just take more orally? That is 100% inaccurate.
Just trying to provide realistic balance with real examples as there is plenty of counting chickens before they hatch here with not enough substance. No one has any idea how the FDA is going to react.
You mean except for the FDA, of course, since they actually review and approve or deny the submission. ELTP coupd be another TTNP, who was courted by FDA and rug was pulled from underneath them. Took them a couple years to resubmit NDA. FDA can easily stop ELTP. Let's not be silly.
12 calendar weeks which brings us to mid-April in worst case scenario. This is assuming FDA hits their own timeline. I would expect they do here. They are more apt to move the date back on the final guidance as this is a new tech. FDA is super understaffed. Will be interesting to see timing in light of opiate issues plaguing the country.
From Jan 13 press release. We have just reached 6 week mark. We are now in window. Could take 6 more weeks. Anyone who says otherwise is creating their own timeline and is not based on what Elite has communicated based on their conversations with the FDA.
"FDA notification regarding acceptance of the submission for review is expected to take 6 to 12 weeks."
Read it for yourself. Don't be fooled by other's propaganda:
http://finance.yahoo.com/news/fda-approves-waiver-nda-filing-215222660.html
Up to mid-April, assuming no delay.
Except that the FDA communicated to Elite that it could be up to 12 weeks to receive notification on acceptance as we have already been told. This puts us at mid-April.
How is that different from today?
Glad you played it safe. Smart move.
I think you missed the critical part in the article you posted that states deterrrant tech can still be abused by just taking more pills.
From the article there are still strong hesitations about ADT tech:
"To date, it's not clear the new formulations actually translate into fewer overdoses or deaths. And most can still be abused when simply swallowed.
I am not convinced that we can engineer our way out of this epidemic, and I would caution against over-relying on abuse deterrent formulations to do so," said Dr. Caleb Alexander of Johns Hopkins University. "
Perhaps that is the issue. Shoes don't appreciate, but shares do. :)
No need to agree. My gains are already a sure thing. LOL
I think this week is still premature. I think we have a few weeks left. I will happily be incorrect if it comes sooner.
No luck is needed. I already have a fantastic return and that has been proven. This is only the beginning if an even better run. Good luck if you are short. Haha!
What is that old adage, "Slow & steady wins the race". Elite's race is only starting to heat up. Buckle up!
You'll be seeing plenty more after that. Eli-216 is well worth the prize. Nasrat has the key to open the floodgates. Can't wait to read of the NDA application acceptance within the few weeks. Just another step closer.
LOL!!! Leadership is so incredibly weak that little Elite's technology will rival that of Pfizer's. I am laughing all the way to the bank since 0.12.
Absolutely not. Eli-200 is first NDA for Elite of which you are very well aware. This NDA will soon be accepted by FDA opening the floodgates for their technology.
Good thing historical performance plays no role for the future value of this company.
Extra! Extra! Read all about it! Positive Phase III results. Only saw it posted 4 times yesterday in case anyone missed the other 3 times. LOL
I think given. At first glance both Dash & Narene acquired same number of shares. Perhaps I opened same one twice. Will validate later this morning.
I think given. At first glance both Dash & Narene acquired same number of shares. Perhaps I opened same one twice. Will validate later this morning.
Did he also say that they won't be able to accurately account for basic revenues? Just curious.
You are talking about 2 completely different things. LOL. Guess what? In case you hadn't heard ELTP has positive phase III news! LOL!!
Of course Carter screwed up.If he didn't screw up why did they have to refile the previous 10 Q? He can't apply basic accounting 101. If he doesn't understand how to recognize revenue what else is wrong with the financials? Based on what we have seen I'm assuming they received an SD as in severe deficiency from a technical standpoint. He doesn't understand freshman accounting. LOL
Well said
In the past Nasrat said he would be hitting the market hard once he had evidence in his hands of ELTP's vaulable product. We have had ELI-200 results for quite some time with little benefit to the stock price. I am not sure if he is just waiting for FDA approval or what, but I think there needs to be a good balance of time allocation towards building pipeline & getting the word out. The more shares sold at these prices will only continue to deflate future price. Perhaps things will start to change once we get a PDUFA date. Some commentary at last CC also depicts similar feelings that there is disappointment in marketing the company & pipeline.
This is water under the bridge at this point. CFO screwed up. There isn't very much action at this company and Carter could't book revenue according to GAAP. This is in accounting 101. I question his ability to keep the books clean. Controls can be improved, but they can't beat basic technical knowledge. Not impressed.
Haha! Really? ELTP dropped positive phase 3 news? No way?!