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A factual statement of something that happens 1 out of 100 times or what?
I am sure you must have done some ground work to support your statement. Mind sharing?
Do not trust the janitor.
Always enjoy both N2K's & your posts. Excellent strategic analysis & insights.
Thanks!
I respect your PERSONAL OPINIONS even though they are highly conservative to the effect that may discourage investors not to buy aggressively.
Well, we will find out on or before July 14, 2016. Thank you.
Well it is also true that so far there is only one state out of 50 has disapproved the use of ADT opioids- the market there is significantly small!
"No matter how many mistakes you make or how slow you progress.... you are still way ahead of everyone who isn't trying." By Tony Robins
I'm sure NH and his great team are doing just fine.
Namtae, don't worry. NH does not work for but only closely with FDA. He knows this is not his job to approve or reject NDAs. So it does not really matter what NH says about the chance of AdCom, we should just let FDA do its job.
Yes, those 5 FDA approved drugs really helped Califf make such conclusion.
This is why Purdue is in deep trouble and ELTP will be taking the advantage with its ELI-200 after July 14, 2016
"Nasrat offered his more optimistic opinion of a 10-20% chance no AdCom"
Sure it's just like when you tell us that you have 10-20% chance no demotion, we take that you sound like ultra conservative. LOL
Good question. It would be better answered when we get the news on or before July 14, 2016.
I do not see any problems with NH managing investors' expectation. Maybe you think managing expectation is the same as misleading.
Simply because such schedule is regarded not necessary.
Remember I told you to report this "scam" to the SEC, FBI & FDA? Have you done it yet?
"many experts feel these bandaid deterrents, which cannot completely solve the abuse problems, will only lead abusers to harder drugs and worse consequences."
I would appreciate if you could cite some relevant comments from a couple of these experts to support your claim.
Has this to be naked shorting? Can short sellers borrow shares from LPC and sell down the pps?
We all know something. This something is in the eyes of the beholder.
"Any communication with the FDA recently from ELI-200? Yes, as I indicate earlier, it’s an active ANDA and they’re asking us a lot of questions, most of which are really simple, nothing out of the ordinary, no missing data, no disagreement on any issues. So far, I’m happy with how things are moving forward."
Go read the transcript.
Nice find, chiga.
I have learned not to get into panic mode when bashers are all over the place.
Regarding the new timeline for up listing, I believe Nasrat makes such decision is possibly due to the reassessment (by ELTP's advisor for technical accounting) of the quality of its internal control.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123360125
Agreed 100%. I just do not feel comfortable with Nasrat for his change in tone after one quarter. He'd better think twice before his talk. And maybe this is the main reason the CC was held a few more day after earning report to give him more time what to tell things right and tell the right things.
I told you to report this "scam" to the SEC, FBI and FDA before. Have you made your report yet or have you forgotten?
Comparing with the last CC, Nasrat had his forward looking descriptions of ELTP unrealistic and this time, seems very pragmatic! LOL!
While I agree what you say here, I also hate to point out that Nasrat did set the up listing as a goal for 2016, whether it is R/S or not. Was this goal set under pressure or not?
Right. I mean what makes him change in tone in such a way that sending a reverse signal to investors that they should not overly expect the development outcomes, not only the NDA, but also up listing, EPIC relationship, etc.
Since Nasrat has long history and experience dealing with FDA, should I take his words that he is now implying FDA is likely to set an ADCOM date in the future, even after the PDUFA date for ELTP?
Drop of over 25% has reflected all the negative factors of NDA, imo.
Now can any one tell me why the CC was not held one day after the release of earning report, as usual?
I thought it was their goal this year as per their presentation slides in April 2016, right?
What marketing group? What's the marketing plan and how many sales people?
So no R/S is to be considered for up listing?
According to the Q3 2016 earning call transcript, "What we are doing with the ELI-202 is utilizing our Naltrexone sequester technology with an Oxy APAP combination. We moved to the clinical trials and the FDA notified us, Dr. Hertz pleaded that it is highly unlikely that we will give anybody the labelling for a product that has APAP and it is because they consider APAP to be the abuse deterrrent. As a matter of fact, the FDA guidelines that came out in 2015 did indicate that, that Oxy APAP and hydro APAP are products that are not used abuse nasally and via injection, that’s not the desired route. People take them orally, why, because the APAP is an irritant, it irritates your nose, so as I just noted. Therefore adding Naltrexone which is an expensive substance and it costs another $15 million, clinical trial does not give us any edge over just using APAP. We do intend to be competitive in this category but we also intend to be intelligent and not with our money on something that’s not going to get us a preferrable – preferred labeling."
I think ELTP still needs to take care of their internal control issues in compliant with Sarbanes Oxley Act prior to uplisting.
Carter Ward said, "We’ve already engaged and we have on a regular basis accounting – technical accounting experts that we consult with, going over a lot of these accounting issues, we are working on our Sarbanes Oxley internal control reviews. If you look at our financial statements we are disclosing that, we have a material weakness in our internal controls, according to Sarbanes Oxley, and that’s something we need to rectify, we plan on rectifying that during this calendar year, the fiscal year that’s almost over, we won’t have enough time to rectify that, but prior to getting on NASDAQ we will have a system of internal control that is effective and be able to give that assertion and that includes having the proper and technical review of our – technical accounting issues. So that’s already been put in place, we prepared white papers on various things that come up from to time for accounting technicalities. So we are doing everything we can to avoid any type of situation that occurred in the past."
http://seekingalpha.com/article/3885716-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q3-2016-results-earnings-call-transcript?part=single
"When we receive a PDUFA date from the FDA, we do expect that we will have a priority review. Several of you were asking: are you confident that you will get a priority review? What I can tell you is this: This is not an Elite special. This is not something that we did, that the FDA is doing for Elite. The FDA’s policy is very simple. Anybody that files an ADF formulation will get the priority review. And during our correspondence with FDA we told them, do we qualify and they said, if you are telling us is the truth, basically once we look at the application we will make that determination but from what you told us it sounds like you qualify for priority review. I am confident that we qualify for priority review because our technology uses the pharmacological approach and it is abuse deterrent. And when we hear an official response from FDA we will definitely notify the stockholders.
............I don’t want any surprises, I don’t want a question from the FDA, I don’t want any delays, and therefore we’re not going to take any chances and we’re going to wait. And to give you an example on here, Pfizer filed their Oxy BID and they got priority review and the FDA at the end of the prior review said we would need three more months to discuss it further and after the three months, they also needed some more time because has not disclosed. "
Hope the above info from the last CC can give you some ideas.
http://seekingalpha.com/article/3885716-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q3-2016-results-earnings-call-transcript?part=single
I am not sure about you but I have been using TA tools for my investments for years and found them useful. I am not saying these tools are crystal balls or anything. It takes time and practice to choose and use the right tools as well as the parameters for each individual user.
A company's fundamental (such as financial statements) also represent historical record and we can also see how the company manages its business (and financial) operations and development. Any deteriorations or improvements do tell us its future prospect & direction. So in this respect, when I want to invest in a stock, I do look at management team & leadership, market, industry, legal, entry of barrier, rivals, suppliers, supporting industries, etc. then consider both fundamental & technical aspects of the company.
In terms of ideal pps, different investors have their own entry point, depending on their own investment objective and time frame. And thus affects movements of stock price. I am not worried about ELTP as I have put my money in since $0.20 and some even over $0.36. I am looking for growth in the next 2 years and buyout in 3 to 5 year time frame.
You are telling us all those technical indicators are worthLESS? Not even a trend can be detected? Or just that you have limited knowledge about TA?
"Those that understand the FDA and are connected with high ranking experts know they can pull the rug out from under a company without a moments notice.
ELTP is gonna learn a nasty lesson with Eli200 and it's July 14th target date.
I believe management already has information to this effect. Try calling and see if you get a straight answer "
I think you are the one who should call the Company and get a straight answer for yourself before letting us know what you have speculated here with no bases. Don't you think so, Namtae?
Thanks. I am now getting much better understanding of the relevance between IR and oral abuse.