Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I thought Percocet was still in the ~12 month window before they revised it down to 10 months? I'd be more than happy to be wrong on this though.
Generics absolutely provide a margin of safety not found in other purely R&D-only companies. Prime example of diversification.
Thanks for setting the record straight.
Wrong.
Yes, I would assume it would be different. My whole point is that Elite's criteria for their Phase 3 trial was not unreasonable and similar to Pfizer's.
Therefore, I'm not sure why anyone would jump to crazy conclusions that their (Elite's) BE trial criteria would be some crazy, outlandish set of hurdles to jump and so dissimilar from other pharmaceutical companies running clinical trials.
Make sense???
AGAIN, all of that post was Phase 3 criteria for both Elite and Pfizer. We don't have the BE trial criteria for Elite but CLEARLY, Elite's Phase 3 criteria was reasonable given the comparative analysis with Pfizer's.
Good lord.
Sheesh. Here we go again. Allow me to expound:
All me to summarize
Exclusion Criteria:
1. Any uncontrolled medical condition. Who defines uncontrolled? The administrator(s) running the trial.
2. Can someone please tell me what an abnormal EKG means? Sure. Any patients with bradycardia (although understandable with athletes), tachycardia, 1st / 2nd / 3rd degree heart blocks, ST elevations, prolonged QT intervals, atrial fibrillation, atrial flutter, PACs, ventricular tachycardia, ventricular fibrillation, PVCs, etc. etc. etc. Plenty of other abnormal rhythms but I think the point is made.
3. We give narcotics for abdominal adhesions. Okay? Cool.
4. So if you have GI problems then you cant be enrolled in this trial Yes.
5. If you have diabetes you cant be enrolled Yes.
6. So if you have lung disease as defined by the investigator you cant be enrolled. Yes.
7. Screening electrolytre abnormalities gets you disqualified Yes.
8. BPH ("having a big prostate) well I geuss that excludes most over 65 y/o Yes.
9. Having an allergy to ANY MEDICATION that is used to treat pain even if its not a narcotic. Yeah... it's a pain medication trial. They don't want patients having serious allergic reactions if they have a known history of allergies with pain medications. Makes sense, right?
10. If you think you will become addicted to our drug you cant be enrolled. "Not be willing to discontinue the prohibited medications, within the allotted time before surgery and throughout the duration of their participation in the study." Yes, that's right. They weren't testing abuse potential in the Phase 3 trial, they were testing safety and efficacy. That's what the HAL studies were for.
11. It you take a blood thinner to prevent stroke. Yes.
12. Hx of active cancer within the last 5 years. Yes.
13. If you take tylenol for pain.
"Use concurrent therapy that could interfere with the evaluation of efficacy or safety parameters in the opinion of the investigator. (eg, any drugs, in the investigators opinion, that may exert significant analgesic properties or act synergistically with oxycodone, morphine, ketorolac, acetaminophen or ibuprofen)." Of course. Why would you take other pain killers during this trial? Kind of defeats the purpose and risks screwing up the results, right?
14. If you have had a seizure or head injury. Yes.
15. Hx of mental illness. Yes.
I know it's already called a "boiler room", but does it actually get even hotter for them this time of year?
In case anyone is looking for actual facts today, see below for the inclusion/exclusion criteria of Elite's completed Phase 3 trial for SequestOx. Easy to see how patients could easily fall out of the study simply due to failure to continually adhere to these criteria.
https://clinicaltrials.gov/ct2/show/NCT02401750?term=Elite+Pharmaceuticals&rank=15
Eligibility
Ages Eligible for Study: 18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Complete the informed consent process as documented by a signed informed consent form (ICF).
Be in generally good health and classified as either PS-1 or PS-2 by the American Society of Anesthetists (ASA) Physical Status Classification System.
Be male or female, age 18 to 75 years, inclusively at the time of screening.
Be scheduled for a primary, unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation (with no collateral procedures)
Female subjects are eligible only if all of the following apply:
Not pregnant (subjects of child-bearing potential must have a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test at screening and a negative urine pregnancy test before surgery);
Not lactating;
Not planning to become pregnant within the duration of study;
Surgically sterile (bilateral tubal ligation or hysterectomy), or at least two years postmenopausal, or is practicing an acceptable form of birth control (defined as the use of an intrauterine device [IUD], a barrier method with spermicide, condoms, any form of hormonal contraceptives, partner with a vasectomy (surgery at least 6 weeks prior to start of surgery) or abstinence ) for at least 3 months prior to the screening visit and agrees to continue acceptable methods of contraception until one week following the last dose of ELI-200.
Be willing to complete the pain assessments and return to clinic as scheduled.
Subjects must experience postoperative pain (Day 1) that is at least moderate as measured by a NRS score ≥ 4 on a 0-10 NRS, less than 9 hours after discontinuing the nerve block.
Exclusion Criteria:
Have an uncontrolled medical condition, serious intercurrent illness, clinically significant general health condition, or extenuating circumstance that may significantly decrease study compliance or otherwise preclude their participation in the study.
Have a clinically significant abnormal electrocardiogram (ECG) at screening as determined by the Investigator.
Have had any type of gastric bypass surgery or have a gastric band. Have previous abdominal surgery within the past year or history of abdominal adhesions, known or suspected paralytic ileus.
Have a history of any medical condition or surgical procedure that would alter the absorption, distribution, metabolism or excretion of oxycodone or any opioid including but not limited to severe chronic diarrhea, chronic constipation, irritable bowel syndrome, or bowel resection.
Have a history of severe bronchial asthma, hypercarbia, or hypoxia (oxygen partial pressure [PO2] <92%) or any respiratory condition that, in the opinion of the investigator, makes the subject unsuitable for the study.
Mild episodic asthma or exercised induced asthma will be allowed.
Have, in the opinion of the investigator, a clinically significant abnormality on their clinical laboratory values (urinalysis, hematology and chemistry) at screening.
Have glycosylated hemoglobin (2c) > 7%.
Have Addison's disease, benign prostatic hyperplasia, or kidney disease or other conditions as outlined in the Investigator's Brochure or the Percocet and Oxycontin Package Inserts that are contraindicated for use.
Have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to Day -1 .
Have made a plasma donation within 7 days prior to Day -1.
Have a known allergy or hypersensitivity to any opioid analgesics, naltrexone, anesthetics (eg, propofol), acetaminophen, NSAIDs (eg, ibuprofen or naproxen, ketorolac) or any of the excipients
Have a known allergy or hypersensitivity to ropivacaine, Mepivacaine, Lidocaine or any related drug.
Have a history of significant intolerance (in the opinion of the investigator) or allergic hypersensitivity reaction to opioid use.
Not be willing to discontinue the prohibited medications, within the allotted time before surgery and throughout the duration of their participation in the study.
Have a history of substance(more than recreational use) or alcohol (more than 14 drinks in a week) abuse within 2 years before screening.
Have a positive drug screen or alcohol screen result.
Use of anti-coagulant agents (eg, Coumadin, heparin, etc)
Have a positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at the screening visit.
Have an active malignancy of any type, or has been diagnosed with cancer within 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
Have dysphagia and/or cannot swallow study medication whole.
Use concurrent therapy that could interfere with the evaluation of efficacy or safety parameters in the opinion of the investigator. (eg, any drugs, in the investigators opinion, that may exert significant analgesic properties or act synergistically with oxycodone, morphine, ketorolac, acetaminophen or ibuprofen).
Have a history of seizures or history of serious head injury.
Must not be a member of a vulnerable population as defined by the Code of Federal Regulations Title 45, Part 46, Section 46.111(b), including but not limited to employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study, or of the Sponsor, or of the Clinical Research Organization.
Have previously participated in a clinical trial using (Oxycodone Hydrochloride Naltrexone Hydrochloride, 1.5 mg or Oxycodone Hydrochloride , Naltrexone Hydrochloride 3.0 mg ).
Have a history of major mental illness that in the opinion of the Investigator may affect the ability of the subject to participate in the study.
Institutionalized subjects will not be eligible for participation.
Been exposed to any investigational agent within 30 days or five half-lives (whichever is longer) prior to check-in for Day 1, Period 1, or is scheduled to receive an investigational device or drug (other than test product) during the course of this study.
Day -1 Exclusions:
1. Have taken any of the following drugs within the indicated times before surgery:
over-the-counter or prescription non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen [Advil®, Motrin®]), acetaminophen, or naproxen sodium (Anaprox®, Aleve®) within 24 hours; a daily dose of 81 mg of aspirin will be allowed (higher doses must be lowered to 81 mg a day by 72 hours prior to surgery).
naproxen sodium sustained-release (Naprelan®) within 72 hours
C-2 inhibitors (such as piroxicam or indomethacin) within 5 days
oxycodone-containing drugs and other analgesic drugs containing opioids within the past 14 days
immediate-release sedating antihistamines, tranquilizers, or hypnotics within at least 6 hours, or long-acting or sustained-released forms of these drugs within at least 7 days of Day -1
Day 1 Exclusion:
1. Have surgical complications (Day -1) that could compromise the safety of the subject or confound the results of the trial or any other reason that, in the opinion of the investigator, makes the subject unsuitable to participate.
Camargo runs the clinical trials tho.
More Swiss cheese theories.
WHOOPSY! LOL.
Still haven't seen an answer to my question but that's cool. Let's try again.
Care to explain why there were zero safety events and the drug was efficacious when tested on 163 people?
Inclusion and exclusion criteria that must've initially been met and then weren't at some point during the study + recruitment issues. If 80% of clinical trials have those issues, then almost all trials would have "red flags" according to your theory.
Care to explain why there were zero safety events and the drug was efficacious when tested on 163 people?
Thanks Weezy.
I wonder if we see any updates soon regarding the generic ER Oxy ADT.
Where do you see the info about 5 patients being dropped related to SSI?
It was supposed to be .02 or subpenny tho. Lololol.
Well I don't know about ZERO percent of that happening...
Did you figure in plagues of locusts, rivers of blood, and/or alien abductions???
Climbing back up!
Lol who said no news in June?
Yup so far!
You and me both, Kenny. Lmao
Yeah the .02 and sub penny calls were good ones too. lol
Panic selling idiots, that's why. No cojones.
Lol k. If the CRL didn't do it, a couple month delay in a trial certainly won't. Keep trying though, it's amusing.
After the CRL, tell me again how it was supposed to go to .02 and then sub penny. Almost a year since that failed prediction.
Quote it then, should be easy to prove. Thanks.
Nah actually he didn't though, thanks.
Sounds good to me!
Someone REALLY doesn't want us going back over .20 yet.
He didn't say Trimipramine was an orphan drug.
Yeah no rush on the .02s, we've already been waiting several years now. LOL.
Sounds that way because it is.
About what?
Did you see that we tanked green again?!
Bingo. Nice post.
I don't know who made them. The claim was made that there is no pre or post market ELTP trading and I just proved that false, period.
100K Buy at the ask just now
Are you denying that 3 pre-market trades just happened? I saw it and also snagged a picture. Lol. 10k, 20k, and 50k trades all went through before the bell.
Never said I did it, just that it happened.
3 trades - 70k traded premarket.
Boom right there. Pre-market.