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new month. no default judgment filed...
growing more or less certain JP...
jugs see my previous post. it's a realistic assessment for how and when this ends. JP is not providing a service. he is crying on the internet and making false comments about motivations, events, and with impossible certainty. not for a second do I believe he has any inside information, or the ear of someone in the know that makes his comments legintimate. fake news is not a service to potential investors.
Confucius say, "give it a rest JP."
so 100% that's what is going down?
man, i wish i was that sure about stuff
I'll give you mine. 50% chance this ends end of September, 30% chance this ends in February, 20% chance deal goes through
JP, you've been predicting Magna wants there money back every week since god knows when. Give me three guesses, dates with probabilities. when do they "pull the plug and auction the IP"
JP the fundamental challenge of finance is the vacuum of knowledge that exists between various insiders and outsiders. We are all outsiders. No one can 'splain exactly, all we can do it try. Request you don't post my stuff cross-site.
dude, I'm essentially quoting him. He has almost nothing in the game right now. He made money helping Gerald before. Some people have a longer term vision than the next paycheck. They have a relationship. Clearly he doesn't do much IR for them so it's not like its a huge favor...
You cop a clue. This has a chance of turning around and if it does it's huge. It probably won't. Everyone is clear on this. But there's still a chance and its not 1/million either. Ever think the guys at Magna evaluate the worth of a healthy relationship with Gerald and other young biotechs. They do. Don't know how much it's worht, but it's at least been worth some flexibility.
Rich is doing IR out of the goodness of his own heart. Call him. Game isn't over.
Not dead until they declare it dead or Feb of 2018, per LOI... quit making stuff up
"Biomedical science has become increasingly vital. Global BioLife is taking steps toward providing solutions to issues that have plagued the biomedical field for decades. This working collaboration marks a first steps in actively changing the game of healthcare," said Chan Heng Fai, SeD Executive Chairman and Chief Executive Officer, and a Global BioLife Director.
it is all fixed. The FDA just hasn't adjudicated and notified them.
no approvals until warning letter resolved. They expect successful resolution.
Clearly the company is announcing a pivot away from SequestOX. Doesn't mean they won't turn that around, but I don't expect to hear anything on it til next Spring when they'll either be ready for a pivotal or will have decided not to proceed.
This company is much bigger that SequestOx, but it will need sometime to recoup. The value and potential still exist. But sounds like LPC will be spent regularly.
Questions for the ELTP Conference Call
It may be helpful if we all add questions to a list of questions with the understanding that we send the questions to Dianne Will. This way we can keep track of what questions have been requested to be answered during the CC. Just copy and paste the questions and add yours to the bottom of the list.
For starters:
1) Besides generics, what drugs is ELTP working on that the company anticipates filing with the FDA for approval in the next twelve months?
2. What is the status of the generic Oxy filing, other unsubmitted ANDA's and the submitted ANDA's. Timelines seem to be slipping.
3. What is the status of SequestOx discussions with the FDA. Is there any reason to believe the FDA might revert back to it's previous position of only requiring labeling? What is the estimated timeline of events.
4a. With the previous CRL, the company suggested the idea that there was no negative commentary on the ADT technology. Was anything positive said to acknowledge or validate it's success? Was there validation that the abuse resistance studies were in fact sufficient evidence?
4b. If so, given the odd position of SequestOx, why not proceed on an ER product to give us more shots in a timeframe.
5. If SequestOx in current formulation is dead, is the next step a third formulation? If so, what are the advantages and disadvantages of the next formulation considering it's not been the best bet so far. Why should investors expect the third to succeed?
6.Why did ELTP decide to give SunGen 50% of our ER ADF line in the "mutual" partnership to bring other (unstated) generic drugs to market? In what way does this partnership advance us rather than going it alone? Does this indicate entrance into the Chinese market, plans to do so, and do you also plan to advance Sequestox into Canada/China/EU while you await the FDA?
7. Given a sp of .11-.12 and almost a billion O/S, how do you see the company capitalizing future R&D endeavors without further dilution by LPC or performing an R/S followed by dilution? What sources of funding are you relying on?
8. How is market penetration coming on the new products?
9. What is the purpose and shelf life of the approximately $5M in raw materials in inventory? Q over Q suggest these are not going toward rapidly growing products at market.
much ado about nothing. We did a lot of R&D. We saw the iffy results. We're sitting on a boatload of raw materials that we aren't converting at an aggressive rate. Maybe that was due to anticipating all these SunGen deals or that the Tmax data might be definitively good. But that's worrisome. I now also want to know the shelf life of that $5M of raw goods. No evidence of generic growth here, but not of shrinkage either. Same story, getting out of the business of contract manufacturing.
We have to hear about SequestOx progress. That is all. This 10Q is a bland report. Nothing good or bad. The company is floating until we can move on SequestOx or something else.
Questions for the ELTP Conference Call
It may be helpful if we all add questions to a list of questions with the understanding that we send the questions to Dianne Will. This way we can keep track of what questions have been requested to be answered during the CC. Just copy and paste the questions and add yours to the bottom of the list.
For starters:
1) Besides generics, what drugs is ELTP working on that the company anticipates filing with the FDA for approval in the next twelve months?
2. What is the status of the generic Oxy filing, other unsubmitted ANDA's and the submitted ANDA's. Timelines seem to be slipping.
3. What is the status of SequestOx discussions with the FDA. Is there any reason to believe the FDA might revert back to it's previous position of only requiring labeling? What is the estimated timeline of events.
4a. With the previous CRL, the company suggested the idea that there was no negative commentary on the ADT technology. Was anything positive said to acknowledge or validate it's success? Was there validation that the abuse resistance studies were in fact sufficient evidence?
4b. If so, given the odd position of SequestOx, why not proceed on an ER product to give us more shots in a timeframe.
5. If SequestOx in current formulation is dead, is the next step a third formulation? If so, what are the advantages and disadvantages of the next formulation considering it's not been the best bet so far. Why should investors expect the third to succeed?
JP, why did the MM's paint this down last second of the day?
JP, why are the MM's letting this rise?
it's worth more alive than dead
Per informed sources... Elaborate
I think the rule we've learned is GC always finds a way. Usually, the solution is unexpected, a combo out of the blue that catches us off guard. The question is are we so undervalued that no permanent solution could hurt us?
Expect FED results July 19th ish, based on NAS words and the reality of data prep over periods covering a holiday. Expect other PR to jump start run up to settle around .30 before results. From there, if positive and path/timeline forward is clear, expect us to pop back up to .45 or so.
based on the chart I'm thinking sometime next week or early the week thereafter we pop up about the same time the 50 and 200 meet again
dude, you're so full of it. You thought an LOI would be canceled on the goal date. That's n00b stuff. Quit baggin on the process. Wait around like the rest of us or don't. But you don't know squat
it was subtly disguised propaganda, but still got editors pick, and puts the name out there. When good news comes around, and more people research it will be nice to have that article hanging out there.
JP, it's past June 25. Why didn't CHF pull out today?
Seeking Alpha article: opioid-abuse-epidemic-investment-angle
guy goes long ELTP along with some big names.
Let's go.
They are coming. Chinese m&a cycle begins again. Humanwell too. Agic check the wall street journal
Serious question. I was reading over EGLT, a competitor who has an upcoming IR ADT PDUFA.
As you all might recall, theire ER ADT only got a single ADT label, not the trifecta. I read the following "The good news: the company received approval in Jan. 2017 and will be selling ARYMO ER in 2Q17; the unexpected bad news: the FDA permitted the label to state that ARYMO was an AD product by the intravenous route of abuse, but not oral or nasal routes of abuse, because a competing product (MorphaBond by privately-held Inspirion Delivery Sciences) was granted a three-year label exclusivity for the other routes of abuse when it was approved in October 2015." from Bret Jensen.
The question is, are we in danger, if SequestOX does not reach labeling first, at missing out on the labeling if we are not first?
you answered a lot of questions I didn't bring up. I didn't take issue with the why, I took issue with the mechanism. It's ok not to be familiar with the mechanisms and how they play out. I am. Your comment on attorney retention is way off, too many parties who can afford attorneys at odds with each other and GC would find the cash, really not THAT expensive until you try to pay to prevent at all costs.
Since you didn't disagree with the times or the mechanisms, let the argument stand, that there is play yet in this stock, for many many months ahead either way.
to be clear, even if actions were taken to "seize" the IP and start taking AMBS to BK etc, that would be a long drawn out process with plenty of its own problems. Many times a company enters BK protection and there will be significant spikes in share price as rumors swirl, or legal interventions occur, that rstore hope of an upside. enter the Q zone doesn't always mean a loss, just most of the time, and there's opportunity until the fat lady sings.
6 weeks
I've got to eat crow on the revenue being less than $10M. Methadone contract. No bueno. Credit to whoever figured that one.
just available I think implies that it wouldn't be used much at all...
Dianne,
Continued congrats to everyone at Elite!
For the upcoming conference call, I respectfully request comments on the following questions:
With regard to the SequestOx II studies necessary to satisfy the NDA resubmission what is the status of each, and what is the schedule going forward for submission and response?
What recruitment issues occurred, why were they so extensive as to delay the study over a month, and why were they not anticipated?
With the previous PDUFA validating much of the rest of the ER ADT pipeline, why aren't we at least making some inexpensive progress on studies necessary for further ADT NDAs?
What was the business basis of the Trimipramine transaction as opposed to the other holdings available from Mikah and other parties?
Does Elite intend to utilize the Lincoln Park money and how, or is it merely helpful to have it available?
Very Respectfully,
no way revenues have decreased by millions...dude how? you threw the plural in there, not me.
Consolidated revenues for Fiscal 2016 were a record $12.5 million. As of Dec 31 2015 revenue was $7,303,488
Revenue for 9 months ending dec 31 2016 was 8,287,493 with some backlog, allegedly. If the backlog was baloney or something else negative happened, we're on pace for $11M. If the backlog was true, and recall, there is evidence on the balance sheet of such to the tune of $1M, then we are looking at matching revenue more or less outside of bonuses, which is growth in revenue. We either had extra product on hand and didn't have to spend as much this quarter, or the sale was delayed. No one ever gave a shit about those milestones when evaluating revenue, again, it's only that we can be that much more cash stable. We ought to have $14-15M cash on hand too. That's solid performance.
The company would be wise to dilute a little in the run up to results, but the run up will happen, justifiably as people position before an event.
there's a chance revenue falls slightly without the bonuses. most likely scenario is a slight rise, I predict 8%. also a chance, with the backup, we blow this quarter out of the water. That would be a nice domino to fall first over the next month. inventory hold, like the recruitment problems, may have been very savvy head fakes to establish accelerating growth numbers.
It is hardly a matter for upside. Generic growth defines the downside for the time being, per our ability to avoid extensive destructive financing and endure headwinds. I acknowledge these ANDAs could be significant, but it's really unknown, the space is crowded, the FDA is starting to squeeze non ADT. We need a solid set of SequestOx data, and a transparent display of the results.
A solid YoY beat, ANDA file, solid SequestOxII data, and a successful NDA will make dreamy talk a reality. Failures on any front will change the future, but none more so than July data.