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Isradapine Parkinson’s 3 year $23 million dollar Study
The problem with DHPs from a therapeutic perspective, however, is that they are not selective12. LTCCs are a heterogenous class of multi-subunit ion channels13,14 that can be divided into four classes based on the identity of their pore-forming alpha 1 subunit, CaV1.1-4. This pore-forming subunit governs key features of the channel, including gating and pharmacology. The predominant (~90%) LTCC in the brain has a CaV1.2 subunit; this channel also is abundant in a variety of peripheral organ systems, including the cardiovascular system and is effectively antagonized by DHPs, accounting for their therapeutic efficacy in hypertension15. However, the LTCC responsible for mitochondrial oxidant stress and increased vulnerability in SNc dopaminergic neurons is largely attributable to expression of LTCCs with a CaV1.3 subunit5,6. Among the DHPs, isradipine has the highest relative affinity for CaV1.3 LTCCs, but it is still CaV1.2 LTCC selective14. This diminishes the therapeutic potential of DHPs in PD, as cardiovascular side effects limit the dosing and antagonism of CaV1.3 LTCCs.
When do you expect results to be made public of the trial
About the Conference
The Parkinson's Disease Therapeutics Conference is The Michael J. Fox Foundation's annual scientific conference and the only one in the world focused exclusively on Parkinson's disease drug development. The 12th Annual PD Therapeutics Conference will be held on October 25, 2018 at Convene Midtown East, New York City.
We are delighted to have Carole Ho, MD chair our 2018 event.
The PD Therapeutics Conference brings together 300 research and business development professionals from both academia and industry and showcases the most exciting and innovative research from MJFF's research portfolio. Novel advances in basic and translational research from both academic and industry labs are highlighted through speaker presentations and a poster session. The event is a platform for field leaders to share new and unpublished results and for fostering new relationships and collaborations.
Isradapine Parkinson’s 3 year $23 million dollar Study nearly completed
“If it proves to be effective, this drug will change the way we treat Parkinson’s disease, and the major advantage of it is that isradipine is already widely available, inexpensive and will allow for rapid translation of our research into clinical practice,” said Tanya Simuni, MD, principal investigator of the study and professor of neurology at Northwestern University Feinberg School of Medicine. “Although we now have very effective symptomatic treatments to manage Parkinson’s, the development of a disease-modifying intervention remains the Holy Grail.”
"Nifedipine can easily cross the
brain–blood barrier (1); thus, it may have a direct effect in the
brain. "
gee I was told only isradipinew crossed the bbb
False.
8. I have presented evidence that this effect of isradipine if thereis one may in fact be an effect that can be achieved with all or any CCB
Hey Kids! Wanna be bigger than The Beatles?
The Drug That Helped Turn the Beatles into the World's Greatest Band
Officially known as phenmetrazine and sold under the name Predulin, the drug was popular in Europe in the late 1950s and early 1960s. Prellies were especially easy to obtain in Hamburg's red light district, St. Pauli. Sold as a diet pill, prellies became the drug of choice for the Beatles and other bands looking to stay sharp and awake. Tony Sheridan -- whose "My Bonnie" features the Beatles as a backing band, the group's first recording -- helped introduce the Beatles to the drug in 1961, during their second trip to Hamburg. "Here's something to keep you awake," he reportedly told the group.
Old speed freaks wax nostalgic about prellies like they do every drug that's no longer around. It's "said by many old, old, incredibly old school speed freaks that phenmetrazine was a far superior drug to benzedrine or dexedrine," writes a user on drug discussion forum Bluelight (I cleaned up his spelling). A drug that metabolizes into phenmetrazine, phendimetrazine, is still available on the market. As a Schedule III drug, it can be prescribed in the United States -- but it rarely is. As you can tell by the lack of a clever slang nickname for phendimetrazine, it's not very popular on the recreational market.
George Harrison and Sutcliffe were regular users of prellies, but John Lennon was the heaviest in the group. "Two pills a night were more than enough for most," Lewisohn writes, "but John frequently took four or five, and in conjunction with hour after hour of booze he became wired, a high-speed gabbing blur of talent, torment and hilarity." He even tormented Paul McCartney into taking the drugs, like in an after-school PSA. Even after he started taking them -- "maybe I'd have one to last the night," McCartney said -- Lennon continued to torment him for not taking enough drugs.
isradipine, can buy 100 5 mg from Teva for 119.98
or 100 5 mg from epic (elite) for $179.83
wonder why Hakimus is developing another ADF oxy that doesn't include naltrexone?
10? 20? 30? WeeZuhl would be the one to ask to get the best answer for this topic.
Amigo Mike talks, I listen.
I retract my previous opinion and associate myself with Amigo Mike's explanation from the dark web. He is consistently correct on these structure & finance issues. Amigo Mike, why do you treat us this way and make us go looking all over the internet for your informed opinions? The great unwashed need your gospel. Thank you.
You all need to go back and read very carefullly the company PRs for the last several financings. This one simple statement in the filing pretty much clarifies what is happening here.
>>>>>Represents 6,858,334 Common Shares issuable upon the exercise of certain outstanding warrants at exercise prices of $0.60, $1.25, $0.75 or $1.375 per share, to be offered and sold by the selling shareholders named in this registration statement.<<<<<
ALL OF THE WARRANTS ISSUED WITH ALL THE MOST RECENT FINANCINGS WERE UNREGISTERED WARRANTS .......thus requires a REGISTRATION STATEMENT be filed with the SEC in order to gain registration approval.
THESE SHARES DON”T EVEN EXIST. And IPCI didn’t “sell” any warrants. The shares only exist if the warrants are exercised, which at the named prices (THAT YOU CAN TIE BACKWARDS TO ALL THE RECENT FINANCINGS) ..... they won’t be unless the stock price advances ..... or they are repriced. And the warrants are worthless given the exercise price vs current price. They only have tangible value if the stock price is higher at some point during the exercise period.
The filing at this point in time means NOTHING and is a simple formality.
Amigo Mike
Not so hard to figure out.
They sold 6.6 million warrants for enough cash to get them through the reverse split. The good news is that if the share price doesn't go above .60 then there won't be any more dilution. The bad news is that this will not get them to NASDAQ compliance, and the real dilution will come after the reverse split.
No mention of how much cash they got for 6.6 million warrants or to whom they sold them. In typical IPCI fashion, they are treating their shareholders like mushrooms- keeping them in the dark and feeding them shit.
For the record.
Accepting a generous compensation package from a company that he is a major shareholder of is not consistent with enhancing shareholder value. Just remember--to pay Nasrat cash for his income, the company is selling shares at less than .10 to LPC.
Nasrat's willingness to accept stock in lieu of cash for payment of salary and bonus, at his insistence I might add, speaks volumes as to his opinion of Elite's future potential," said Jerry Treppel, Chairman of Elite Pharmaceuticals.
I am Elite's number one stockholder. I have always believed in Elite's stock so much that I have never been paid a paycheck by this company except in stocks. Elite pays me in stocks every single paycheck. Every time Carter issues me restricted stocks in salary, I have to pay taxes on it. I've had to pay for three years. I had to pay the IRS on stocks that are really not cash, and I was paying 40% to 50% in taxes on money that I have not seen, okay.
here are but a few
and I guarantee there are already approved isradipine products in all, thanks
really???
https://www.pharmacompass.com/eu-ctd-dossier-marketing-authorisation/isradipine
hmmmm facts matter
No reason why we couldn't help millions of people worldwide.
really? why would (for example) europeans buy elite isradipine when there are many approved european products already on the market??????
say, how many products does elite sell in europe- just curious LOL
No reason why we couldn't help millions of people worldwide.
Will be red Thursday to fill the gap as if the PR never even happened.
She's a real beauty.
Nasrat's baby coming home in October. It is already manufactured at the Northvale plant, which is a GMP-certified and DEA-registered facility. I have acquired a fair share of ownership in both the factory and the isradipine ANDA. Makes me proud to think that something I own could provide substantial benefit to hundreds of thousands of people. No reason why we couldn't help millions of people worldwide.
This is really interesting can somebody find when they first filed: did we file first? Did they file first; this is really weird I agree Way way too much of a coincidence
07/02/2018 OXYCODONE AND ACETAMINOPHEN ANDA #203864 EPIC PHARMA LLC Approval
07/02/2018 OXYCODONE AND ACETAMINOPHEN ANDA #209385 ELITE LABS INC Approval
The Michael J. Fox Foundation (MJFF) funded pre-clinical work to make that connection, as well as the Phase II trial. In 2014, isradipine researchers received a $23 million grant from the National Institutes of Health to move the Safety, Tolerability and Efficacy Assessment of Dynacirc® for PD (STEADY-PD) study into Phase III efficacy testing.
Awesome news today!
This is exactly what we needed. Just wait and see. FDA Approvals are like whizzing at the ballpark. You may go five innings before the first one, but then it’s like every inning after that. Who cares how many competitors, fire up the factory. Bring on Norco! Bring on methadone! Free the hostage Mikah drugs now!
Lol Apples to oranges. Fortune 500 are solid businesses. Elite’s Methadone contract being eliminated has significantly impacted revenues. One small and simple contract. *poof*
Fortune 500. Lol
Five studies involving 208?248 CCB users were identified.
Let’s do 1/4 the market to keep it conservative.
Each patient pays $1200/ year.
Hello Dianne,
We're all looking forward to the STEADY-PD Phase 3 results to be published in early 2019. As far as I can tell, isradipine is not currently available in Canada. Would the company consider applying with HealthCanada to market isradipine? I read there are an estimated 100,000 patients with Parkinson's Disease in Canada. If the study results are good, those patients are going to need a reliable supplier of the drug. Maybe that could be Elite!
Thanks,
sure FDA likes it when companies charge higher prices for generics, that otherwise would be available for a fraction of the cost. Yep, FDA likes that LOL
We need projected revenues for Isradipine for 1/2 million Parkinson patients.
Guidance for Industry
Changes to an Approved NDA or ANDA
B. Major Changes (Prior Approval Supplement)
1. Changes based on postmarketing study results, including, but not limited to, labeling changes associated with new indications and usage.
Has the interim analysis been published?
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."
I think Glenmark will be our partner for the Unique ADT IR line of products.
...the contract with Epic regarding this specific manufacturing and supply agreement expires in October of 2018. We intend to bring all of these products home to Elite and we intend to launch them by 2019.
...the Alliance with Glenmark includes the ability to expand and add more products. Glenmark's marketing capabilities and resources are well established and they are significant. Expanding the product lines in our alliance is something both of us are interested in. So, the potential is great, and we're optimistic as to the future of the Elite-Glenmark strategic alliance.
One such study is STEADY-PD III, a Phase III trial evaluating the ability of isradipine (a blood pressure drug) to slow or stop PD progression. This National Institutes of Health (NIH)-funded study, however, completed recruitment six months ahead of schedule, driving a potential new PD therapy forward faster and setting precedent for future investigations.
Isradipine is approved by the U.S. Food and Drug Administration (FDA) to treat high blood pressure. Pre-clinical studies and an MJFF-funded Phase II trial demonstrated isradipine has potential to prevent death of dopamine-producing cells and slow Parkinson's progression. An example of a repurposed therapy in PD, isradipine must still undergo rigorous testing to prove it is safe and efficacious for people with Parkinson's.
It's quite much enough if it reduces effect of two tablets to effect of 1½ conventional tablets.
Good point. Think about it.
Don’t forget that podras has received expedited approval status.
Remoxy AdComm
Pain not expecting an approval after Remoxy documents posted this morning???!!!!!!
DRAFT QUESTIONS
1. DISCUSSION: Please discuss whether the Applicant has demonstrated that Remoxy ER (oxycodone extended-release capsules) has properties that can be expected to deter abuse, commenting on each of the following routes of abuse:
a. Oral
b. Nasal
c. Intravenous
2. DISCUSSION: Please discuss whether there are sufficient data to support inclusion of language regarding abuse-deterrent properties in the product label for Remoxy ER,commenting on support for abuse-deterrent effects for each of the following routes of abuse:
a. Oral
b. Nasal
c. Intravenous
3. DISCUSSION: The Applicant is requesting approval of Remoxy ER as an analgesic with properties expected to deter abuse by the intravenous, and intranasal routes. Discuss whether you have any concerns regarding the impact of Remoxy ER on public health. Take into consideration its potential effect on abuse of extended-release oxycodone as well as potential consequences of administration of this product by unintended routes.
4. VOTE: Based on the data presented and the discussions about the data, do the efficacy, safety and risk-benefit profile of Remoxy ER support the approval of this application?
As with all NDA products, FDA intends to consider opioids with abuse-deterrent properties within the context of available therapy. The standard against which each product’s abuse deterrent properties are evaluated will depend on the range of abuse-deterrent and non-abuse deterrent products on the market at the time of that application
A Stamford art gallery owner was arrested and charged with a criminal misdemeanor and a felony Friday morning after dropping an 800-pound steel sculpture of a bent, burnt heroin spoon in front of Purdue Pharma, a top manufacturer of opioids, and then refusing to remove it.
If anything the fact that they've given such an early record date and late shareholder vote date...it's looking more and more likely that whatever's coming for s/h's to vote on is not a reverse split...otherwise it wouldnt be getting rolled out the way it's being rolled out...and the market wouldnt be performing the way its performing.
That's pretty flimsy evidence.
wee, here is my source the company bylaws.
ARTICLE SIX -
SHARE CERTIFICATES AND DIVIDENDS
6.01
Share Certificates:
Share certificates shall be in such forms as the board by resolution shall approve from time to time
The Canada Business Corporations Act (CBCA) and its progeny (e.g. Ontario) handle forward and reverse splits homogeneously: both presuppose an amendment to the articles approved by a special resolution of the shareholders[3]. Having rejected the notion of par value stock, in theory it should have been possible to subdivide / consolidate shares without going through the amendment process. However, the CBCA considers that a stock split is a “fundamental adjustment in the outstanding share capital of a corporation and may therefore be construed as a matter properly allocated to the shareholders”[4]. The amendment will not give rise to special voting rights by the class of shares that is forward/reverse split unless the rights and privileges attached to the shares are somehow affected, viz. in the event of a reclassification.
[3] CBCA, 173(1)(h); OBCA, 168(1)(h)
[4] Industry Canada. Canada Business Corporations Act Discussion Paper: Proposals for Technical Amendments. Ottawa: Industry Canada, 1995, p. 73-74
wee, while what you stated is accurate, they do not need to call a special meeting to do a reverse split. They could just do it.
Remember what a RS does. You can not change 2+2. A RS does NOT A THING, NOT A PENNY, for the MC. If they hqd a MC that was in compliance then YES a RS WOULD make sense.
Intellipharmaceutics Receives Delisting Determination from NASDAQ Staff; Company to Request Hearing
April 24, 2018
TORONTO, ON / ACCESSWIRE / April 23, 2018 / Intellipharmaceutics International Inc. (NASDAQ: IPCI 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, today announced that it has received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC ("Nasdaq") indicating that the Staff has determined to delist the Company's securities from Nasdaq. On September 20, 2017, Staff notified the Company that it did not comply with the minimum $2.5 million stockholders' equity, $35 million market value of listed securities, or $500,000 of net income from continuing operations requirements set forth in Nasdaq Listing Rules 5550(b)(1), 5550(b)(2), or 5550(b)(3), respectively. The Company was provided a compliance period of 180 days to regain compliance. On March 26, 2018, following disclosure of completion of two financing transactions, the Staff notified the Company of conditional compliance with Listing Rule 5550(b)(1). The conditional compliance was also based on the Company's Form 6-K filed on March 22, 2018, in which the Company indicated its belief that its stockholders' equity was in excess of $2.5 million at that time. However, as described in a Form 6-K filed on April 16, 2018, based on the Company's actual results of operations for the three months ended February 28, 2018, the Company did not believe that it would meet Nasdaq's minimum stockholders' equity requirement if measured as of the date of such Form 6-K.
UBS Group AG, for the benefit and on behalf of UBS Securities LLC and UBS Financial Services Inc., two-wholly owned subsidiaries of UBS AG to which UBS AG has delegated portions of its performance obligations with respect to the Auction Rate Securities Rights issued by UBS AG to certain clients and pursuant to which the securities reported herein have been purchased from such clients.
No and no.
Yes and no. Acetaminophen is considered a deterrent by the FDA for some routes of abuse (e.g., snorting).
Wouldn’t that be quite the positive turn of events for Elite!
Here you go:
0 for 3 on ADF filings. Batting 1000% if measures by failures.
0.0% if measured by success rate, but only a few post facts here other than extreme slants & twists.