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Allow me to reiterate...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147745017
It is important to note that this report is not applicable to isradipine, which is a truly unique situation. This will not be an FDA regulatory decision. The research was not sponsored by Elite, and Elite will not be mentioned in association with the research results. I am not sure the market will appreciate the connection between ELTP and STEADYPD-III, at least until it hits an earnings report. Good results will be good for Elite, the old-fashioned way, by selling more product in response to increased demand. I'll take that all day, but I continue to urge for tempered expectations regarding an immediate effect of isradipine news, even great news.
Great info!
Amerisource Bergen...it's a preferred brand now and as far as I see cheapest available too!!
Ok let’s split hairs, .08-.098... fact is all the great anticaption, but market speaking volumes to the contrary.
can't help but wonder what's going on with the interest in the stock, with all the great things, but yet having a hard time holding on to .09, who's selling, with such great news on having a potential parkinson drug. IMO something sure doesn't look right.
dest_golf Wednesday, 03/27/19 07:39:09 PM
Re: None
Back 8nto the .08 range tomorrow..
IMO something sure doesn't look right.
CLINICAL TRIALS PLENARY SESSION
Tuesday, May 7, 2019
11:00 AM - 11:15 AM
A Phase 3 Study of Isradipine as a Disease Modifying Agent in Patients with Early Parkinson’s disease (STEADY-PD III): Final Study Results
Tanya Simuni MD
Let's not fight disinformation with disinformation.
I am clear on that. My simple and humble observation is that he had filed a form-4 just a month ago showing that he acquired 201,717 ELTP shares @ .1239 costing roughly $25,000.
...
This simple and publically verifiable information shows insiders were buying ELTP at a PPS that is higher than its current levels, during a time that some claimed insiders were dumping.
ATTENTION: The person for whose account the securities to which this notice relates are to be sold hereby represents by signing this notice that he does not know any material adverse information in regard to the current and prospective operations of the Issuer of the securities to be sold which has not been publicly disclosed.
Just posting this again to make sure you saw it.
As I said before, they love to make news at these conferences, and newsworthy results are always embargoed prior to the presentation, so I would not be looking for any abstracts or leaks before the date.
EMBARGO POLICY FOR 2019 AAN ANNUAL MEETING ABSTRACTS
The embargo for emerging science abstracts (formerly known as late-breaking scientific abstracts) to be presented at the AAN Annual Meeting, remains in effect until 12:01 a.m. ET, Friday, May 3, 2019, unless otherwise noted by the AAN Media and Public Relations Department.
Emerging science abstracts are not posted online in advance of the AAN Annual Meeting. Emerging science abstracts are accepted from neurologists, neuroscientists, and other researchers whose work is of major scientific importance, warranting expedited presentation and publication. Key aspects of the research must have been conducted after October 22, 2018.
lol lol I never suggested there was no futility analysis
Not only did the study pass through the futility checkpoint, that checkpoint was complete 3 year data on 168 patients. Many full studies aren't even that big. The study was designed to detect if there was at least 25% slowing of functional decline with isradipine, and it would have been stopped if it didn't look like it was happening after 50% of participants had completed the study.
It is futile to suggest no futility checkpoint...
https://pdfs.semanticscholar.org/7d4c/09dd2d8333277b8ffe287609e0982f0ce26a.pdf
Interim analyses
An interim analysis for futility and efficacy will be performed after primary outcome data are available for the first 168 participants (50%) to enroll. The study will be terminated for futility if the interim analysis shows that the conditional power of rejecting the null hypothesis in favor of a beneficial effect of isradipine is lower than 20% under any scenario that is consistent with the data accrued at that time. A two-sided P-value in favor of isradipine of less than 0.001 will be required to stop for efficacy at the interim analysis. The stringent alpha level for efficacy was chosen so as to have minimal effect on the final P-value, should the study run to completion. In addressing futility, the DSMB will examine a range of possible treatment effects consistent with the data obtained in the study at the time of analysis.
The FDA should have nothing whatsoever to do with anything. As you yourself have stated word has pretty much been mum with regard to this drug and its potential use for PD. Study results will be out in early May.
...
Highly doubt anything has been said about anything with regard to study results. And having said that results are pretty much under lock and key until early May how would anyone be privy to results?
What do you know about the company's intentions for a PR in the event the results are good? Easily justifiable as a material event to try to associate ELTP's isradipine with STEADYPD-III, but very, very sticky territory with the FDA. They tend to frown upon drug companies advocating for an off-label use of any drug.
Trends in company stock prices before the first public announcement differ for companies that report positive vs negative trials. On that point, here is some research that found an impact on the p/s following FDA announcements ...
an unwarranted sense of entitlement from people who feel participant trophies are the same as first place
Your thoughts on why the STEADY-PD III clinical trial results are not listed on the program yet?
They love to make news at these conferences, and if the results are newsworthy, they will most likely be in one of the Plenary Sessions ("Premier sessions highlighting the latest advances in neuroscience and presented by some of the most well known and respected thought leaders in the field of neurology.") If it gets added to a lower level session, probably not good. If it gets added to Saturday's Plenary ("Hot Topics") or Sunday ("Presidential") then we are golden. Tuesday ("Clinical Trials") is probably still okay. If it drops all the way to Friday ("Neurology Year in Review") then we are screwed.
Good post, IB.
Well-reasoned, and I agree with just about all of it. Thanks for the input.
DONT BELIEVE WHAT YOU READ
My wife became a citizen YESTERDAY from Germany. Her son is a career PT there and her cousin is a recently retired GP.
I cant begin to tell you the medical horror stories they all relate..from wait time for DX to scheduling follow up tests and refusal of treatments and "expensive" medicines.
People around the world come here for serious care if they can afford too.
Canadians spend a Gigantic amount of Money for care here.
Can't get it in Canada
The world depends on us.
Oh, and the American SAFTEY NET Takes Care of ALL and Fast.
we have the best healthcare for the patient in the world.
I pay $2 for 60 days of simvastin
I pay $4 for 90 days of BP med
GOOD RX....FREE (NO MEMBERSHIP) and any good pharma place compares GOOD=RX to whatever insurance you have for the lower price.
No need to choose...
I am still not sure whether it was incompetence or corruption.
Intellipharmaceutics Receives Nasdaq Listing Determination; To Begin Trading on the OTC Markets System
https://www.intellipharmaceutics.com/news-media/press-releases/detail/196/intellipharmaceutics-receives-nasdaq-listing-determination
TORONTO, ON / ACCESSWIRE / March 19, 2019 / Intellipharmaceutics International Inc. (Nasdaq and TSX: IPCI) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, announced that today the Company received formal notice that the Nasdaq Hearings Panel had determined to delist the Company's shares from The Nasdaq Stock Market LLC ("Nasdaq") based upon the Company's non-compliance with the $1.00 bid price requirement, as set forth in Nasdaq Listing Rule 5550(a)(2). The suspension of trading on Nasdaq will take effect with the open of business on Thursday, March 21, 2019.
Intellipharmaceutics will remain a public company and anticipates that its shares will be eligible to trade publicly on the OTCQB Venture Market, which is operated by the OTC Markets Group Inc., commencing on Thursday, March 21, 2019. The Company's stock will retain the ticker symbol "IPCI." The Company is also listed on the Toronto Stock Exchange and the Company's non-compliance with Nasdaq's bid price requirement does not impact the Company's listing or trading status on that exchange.
The notice indicated that Nasdaq will ultimately effect the formal delisting of the Company's shares by filing a Form 25 - Notification of Delisting with the Securities and Exchange Commission after all applicable Nasdaq appeal and review periods have expired. The Company does not intend to appeal the delisting determination.
Wow. Wait, what?
It is highly unlikely we get a CRL because this is a generic of Adderall. FDA requirements are far less strenuous. It is not like a brand new unknown drug.
Nobody who has done any DD says that.
ELTP wont benefit from Isradipine approval for PD?
Here's the case being made:
Quote from numbersarefun:
I do not think Elite Pharmaceuticals has ever said anything. The hype is that ELTP would benefit from isradipine for parkinson's research.
According to parkinson-study-group.org homepage, "The PSG has partnered with numerous pharmaceutical companies and the National Institutes of Health (NIH) in bringing new drugs for Parkinson disease to the market including pramipexole, entacapone, rotigotine and rasagiline." Those are expensive drugs called Mirapex, Comtan, Neupro, and Azilect.
Isradipine for parkinson would most likely be manufactured and marketed, under a brand name, by a pharmaceutical. That is probably years away, assuming it works. Don't you need two Phase 3 studies to file an NDA?
Also, isradipine for parkinson has a pending patent by the inventor. I assume the patent holder would license it to some pharmaceutical to gain financially from the research.
Which fact about ELTP and isradipine do you not believe? Is it that Elite is one of two companies that currently manufactures isradipine? Is it that isradipine for Parkinson's Disease passed a Phase 2 safety study, called STEADYPD-II? Do you dispute that a Phase 3 efficacy study of isradipine for Parkinson's (STEADYPD-III) has been done and the results will be released in early May?
Comprehensive DD re: isradipine expectations
I'm still working on getting this info into nice looking spreadsheet format, but I wanted to share with everyone the comprehensive, exhaustive DD I have done on what we can expect for ELTP if STEADYPD-III results are favorable. I have listed below every previous example of when a little-used generic blood pressure drug with only two manufacturers is re-purposed to delay progression of a severely debilitating neuro-degenerative disease with supporting Phase 2 and Phase 3 studies entirely paid for by a private foundation and the NIH. Check it out:
1.
Hope this helps! Have a great weekend.
Friday afternoon...
...eight days after NASDAQ delisting hearing. We could see news after closing. Should I put my chips on red or on black? Which is better: delisting to the OTC -or- NASDAQ extension with reverse split? Hard to say either option is a win. I think I'll keep my chips and hit the bar instead.
No need to mark this post.
I hope I'm wrong but as said before, IMO the Isradipine trial is a bust. I believe the results are definitely known by now and we would start to see it reflected in the volume/SP. Mark this post...
I am guessing 20-25M shares will be sold for about $3-5M.
Wee: just to be clear - presentations were due October 2018 for consideration so for this to be included at this late time it must be very good; my correct on the assumption?
You think they already know the results?
If they already know the results and they are horrible, would they even be releasing the results during this meeting?
Are they purposely releasing the results during this meeting because they are good/great?
What does your gut tell you?
We have a date...
https://scienceofparkinsons.com/2019/02/28/february-2019/#more-52900
STEADY-PD III (isradipine) clinical trial results will be released at the 2019 American Academy of Neurology meeting in Philadephia on the 4th-10th May, 2019.
are you saying those solvents wouldn't affect he naltrexone beads, only the oxy beads? And are we to infer those same three solvents work the same on Sequest beads as the Troxyca/Embeda tablets?
One unique exception appears to be the use of Solvents F, G, H and O on crushed pellets, which selectively extracts naltrexone from oxycodone.
This is further supported by the ability of solvent P to selectively extract oxycodone even in crushed tablets. Solvents I appear to extract oxycodone selectively from crushed tablets.
no addicted person could afford the equipment or have the knowledge it would take to separate the beads. It is absolutely not going to happen on the street.
Panelists were also concerned that the drug, while resistant to abuse via crushing and several types of dissolution, appeared to be easily dissolved in three commonly available solvents that are safe for consumption and easy to obtain, although it might take some time to do so.
"Once the recipe is out there, it doesn't matter if they had 5,000 data points that didn't work," said panelist Jeanmarie Perrone, MD, of the University of Pennsylvania in Philadelphia. "Once you get the one that does work, it will be the one that proliferates, and it's pretty simple based on what we've looked at."
If Elite's Tech can be defeated, where does that leave SequestOx and the complete ART Opioid pipeline?
I disagree.
What everyone needs to understand is that the FDA is always changing what is needed during the approval process, this is no way in any fault of Elite's.
Alternatively, common solvents A and L to N, are generally unable to extract oxycodone
from naltrexone selectively in crushed pellets. One unique exception appears to be the
use of Solvents F, G, H and O on crushed pellets, which selectively extracts naltrexone
from oxycodone. Of the common solvents I and P, solvent P selectively extracts the
oxycodone in a manner that appears dependent on the intrinsic solubility of the two APIs,
not on the delayed release of naltrexone by the sequestering membrane. This is further
supported by the ability of solvent P to selectively extract oxycodone even in crushed
tablets. Solvents I appear to extract oxycodone selectively from crushed tablets
Complete nonsense.
200 Americans died of an overdose of opioid-based pain killer every day. Not junkies! Fathers and mothers of families, pensioners, ... 200 per day!
Those pesky material facts...
How many class action suits are pending at this time? That's probably where the $12 million went... lawyers for the Odidi's.
https://ih.advfn.com/stock-market/NASDAQ/intellipharmaceutics-international-inc-mm-IPCI/stock-news/79352433/prospectus-filed-pursuant-to-rule-424b3-424b3
On February 21, 2019, the Company and its CEO, Dr. Isa Odidi, received a Statement of Claim concerning an action against them in the Superior Court of Justice of Ontario under the caption Victor Romita, plaintiff, and Intellipharmaceutics International Inc and Isa Odidi, defendants, . The action seeks certification as a class action and alleges that certain public statements made by the Company in the period February 29, 2016 to July 26, 2017 knowingly or negligently contained or omitted material facts concerning the Company’s NDA for Oxycodone ER abuse-deterrent oxycodone hydrochloride extended release tablets. The plaintiff alleges that he suffered loss and damages as a result of trading in the Company’s shares on the Toronto Stock Exchange during the above-noted period. The claim seeks, among other remedies, unspecified damages, legal fees and court and other costs as the court may permit. At this time, the action has not been certified as a class action. The Company intends to vigorously defend against the claims asserted in this action.
More States Say Docs Must Offer Naloxone With Opioids
But is co-prescribing the solution?
Don’t be a dumbass. Only idiots pay $4500 for opioid overdose protection! You can make your own WeeZuhl-brand Opioid Overdose Protection (“Oops”) Nasal spray for just a few dollars! Although WeeZuhl-brand Oops Nasal Spray has never been tested in any way, it SHOULD work! And let’s face it, P.O.O.P., as a regular heroin injector, you’re probably not a big stickler for generally-accepted standards of safety and efficacy. Now let’s get busy. You’ll need a few supplies. You need one 3.5 ounce bottle of saline nasal spray (~$5) and two tablets of Elite Pharmaceuticals generic naltrexone 50mg (~$2/tab. You’ll need a prescription for these).
don’t be a heroin addict AND a chump. $4500 Evzio vs. $10 WeeZuhl-brand Oops Nasal Spray is a no-brainer. But remember! Any kind of opioid overdose protection system will only work if you use the Buddy System, and if your buddy is a heroin-addled dufus who does not know what to do then you are still dead. Good luck!
what's your take about the de-delisting ?
RE: Intellipharmaceutics International Inc.
Pursuant to a request from the above-mentioned reporting issuer, we wish to advise you of the following
information in connection with its Annual and Special Meeting of Shareholders:
Date of meeting: April 30, 2019
Record date for notice: March 12, 2019
Record date for voting: March 12, 2019
Beneficial ownership determination date: March 12, 2019
Securities entitled to notice: Common Shares
fabius haiku 4u
As per today Bloomberg's IPCI ownership page there is no sign of Boyd and its fund anymore.
Old but good: REPOST 5/14/15
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=113680277
Generex Provides Data Update from AE37 Phase II Breast Cancer Trial One Year Post Completion of Enrollment
9:30 AM ET, 05/14/2015 - PR Newswire
A prior interim analysis conducted in 2011, as well as a primary efficacy analysis conducted in 2013, pointed to a benefit of the AE37 vaccine in patients not receiving Herceptin and, in particular, patients with triple negative breast cancer. This latter group represents a patient population of high unmet need. The present study continues to show a trend in this population, with a 35% reduction in the relative risk of recurrence in patients receiving the AE37 vaccine.
Congratulations to the Antigen team. This shows there is great promise for AE37, especially for this tough to manage population with triple-negative breast cancer. Nothing else has shown anything near this effective for this group. No way this can be let alone. I think we can expect to hear more soon. I suspect the next step will be a combination trial with at least one other peptide. I suspect it will be with Dr. Mittendorf as primary investigator.
Question: Will the new peptide(s) be hybrid vaccine with Ii-key moeity? I would think so.
Subgroup efficacy evaluation of the AE37 HER2 vaccine in breast cancer patients in the adjuvant setting.
Results: There were no clinicopathologic differences between groups in the 298 enrolled pts (VG = 153, CG = 145). The vaccine is safe and well tolerated. After a median f/u of 55 mo, there was a trend toward improved DFS in the VG among stage IIB/III pts (VG, n = 73, DFS 82% vs CG, n = 61, 67%, HR = 0.48, p = 0.06) and those with low HER2 expression (HER2 LE, VG, n = 68, 89% vs CG, n = 66, 51%, HR = 0.47, p = 0.1). Improved DFS in the VG was documented in patients with both stage IIB/III disease and HER2 LE (VG, n = 39, 90% vs CG, n = 38, 32%, HR 0.3, p = 0.02) and triple negative (TNBC) pts (VG, n = 21, 89% vs CG, n = 21, 0%, HR 0.26, p = 0.05).