Waiting for the next wave...
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Agree. No private company discloses their revenue.
If there is a real link paste it here.
The current vp of Qa has passed 4 Qa audits recently without a ding.
She knows what she is doing. Top notch !!!
The new QA resource may be a requirement from dexcel.
Elite already a top notch Qa Director
I think dexcel have their own technology
The mothership - the Israeli company is much bigger.
They had 6 multi million dollars investments- the latest in July 2021.
Sharkey. Dexcel uk is not that big
Net worth of 10 million pounds is comparable to elite.
So ultimately elite gets a manufacturing price from dexcel. They agree on a floor price that could be 20% higher than manufacturing price. Which would be dexcel profit. And anything above that is profit split. Which is now split between mikah and dexcel. Or mikah dexcel and elite?
Good Purdue sold opioids n the Midwest.
U like that?
M****r f*****r
You take this one down you must take the other one down this is exactly the same effect to me it has on you.
Maybe Dianne is on vacation - she generally replies even if it is a no answer - this time she did not...
Dexcel has also an Opiod addiction treatment...
ViePax XL Dexcel 150 mg Prolonged-Release Tablets
Patient Leaflet Updated 22-Jul-2021 | Dexcel Pharma Ltd
ViePax XL Dexcel 150 mg Prolonged-Release Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIEPAXTM XL DEXCEL 150 mg PROLONGED-RELEASE TABLETS
Venlafaxine
IMPORTANT THINGS YOU SHOULD KNOW ABOUT VIEPAX XL DEXCEL 150 mg PROLONGED-RELEASE TABLETS
Please read all of this leaflet before you start to take your medicine as it contains important information about ViePax XL Dexcel prolonged-release tablets (referred to as ViePax XL Dexcel throughout this leaflet.)
ViePax XL Dexcel is used to treat depression, severe and persistent anxiety known as generalised anxiety disorder (GAD), social anxiety disorder (also known as social phobia) and panic disorder (panic attacks)
ViePax XL Dexcel is not for use in children and adolescents – see in section 2 ‘Children and adolescents’
Re: "There is an Elite Pharma in Cairo"
Nice to know - there is also a company manufacturing sweets in Israel named Elite... so what?
The point is what are the chances having a recent Dexcel document containing ELITE I and ELITE II studies...
Is this really a coincidence or has Nasrat been in touch with them dor a while?
Losartan potassium 50 mg film-coated tablets
This is the drug Elite and Dexcel partner on !!!
https://www.medicines.org.uk/emc/product/9045/smpc#gref
4. Clinical particulars
4.1 Therapeutic indications
• Treatment of essential hypertension in adults and in children and adolescents 6-18 years of age.
• Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment (see sections 4.3, 4.4, 4.5 and 5.1).
• Treatment of chronic heart failure in adult patients when treatment with Angiotensin converting enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction ≤ 40% and should be clinically stable and on an established treatment regimen for chronic heart failure.
• Reduction in the risk of stroke in adult hypertensive patients with left ventricular
hypertrophy documented by ECG (see section 5.1 LIFE study, Race).
4.2 Posology and method of administration
Posology
Hypertension
The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning). Losartan Tablets may be administered alone or with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide) (see sections 4.3, 4.4, 4.5 and 5.1).
Hypertensive type II diabetic patients with proteinuria ≥ 0.5 g/day
The usual starting dose is 50 mg once daily. The dose may be increased to 100 mg once daily based on blood pressure response from one month onwards after initiation of therapy. Losartan Tablets may be administered with other antihypertensive agents (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) (see sections 4.3, 4.4, 4.5 and 5.1) as well as with insulin and other commonly used hypoglyceamic agents (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Heart Failure
The usual initial dose of Losartan Tablets in patients with heart failure is 12.5 mg once daily. The dose should generally be titrated at weekly intervals (i.e. 12.5 mg daily, 25 mg daily, 50 mg daily, 100 mg daily, up to a maximum dose of 150 mg once daily) as tolerated by the patient.
Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG
The usual starting dose is 50 mg of Losartan Tablets once daily. A low dose of hydrochlorothiazide should be added and/or the dose of Losartan Tablets should be increased to 100 mg once daily based on blood pressure response.
Special populations
Use in patients with intravascular volume depletion:
For patients with intravascular volume-depletion (e.g. those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see section 4.4).
Use in patients with renal impairment and haemodialysis patients:
No initial dosage adjustment is necessary in patients with renal impairment and in haemodialysis patients.
Use in patients with hepatic impairment:
A lower dose should be considered for patients with a history of hepatic impairment. There is no therapeutic experience in patients with severe hepatic impairment. Therefore, losartan is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Pediatric population
6 months – less than 6 years
The safety and efficacy of children aged 6 months to less than 6 years has not been established. Currently available data are described in sections 5.1 and 5.2 but no recommendation on posology can be made.
6 years to 18 years
For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients >20 to <50 kg. (In exceptional cases the dose can be increased to a maximum of 50 mg once daily). Dosage should be adjusted according to blood pressure response.
In patients >50 kg, the usual dose is 50 mg once daily. In exceptional cases the dose can be adjusted to a maximum of 100 mg once daily. Doses above 1.4 mg/ kg (or in excess of 100 mg) daily have not been studied in paediatric patients.
Losartan is not recommended for use in children under 6 years old, as limited data are available in these patient groups.
It is not recommended in children with glomerular filtration rate < 30 ml/ min / 1.73 m2, as no data are available (see also section 4.4).
Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
Use in Elderly
Although consideration should be given to initiating therapy with 25 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Method of administration
Losartan tablets should be swallowed with a glass of water.
Losartan Tablets may be administered with or without food.
4.3 Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in sections 4.4 and 6.1.
• 2nd and 3rd trimester of pregnancy (see sections 4.4 and 4.6)
• Severe hepatic impairment
• The concomitant use of losartan with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
4.4 Special warnings and precautions for use
Hypersensitivity
Angioedema. Patients with a history of angioedema (swelling of the face, lips, throat, and/ or tongue) should be closely monitored (See section 4.8).
Hypotension and Electrolyte/Fluid Imbalance
Symptomatic hypotension, especially after the first dose and after increasing of the dose, may occur in patients who are volume- and/or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. These conditions should be corrected prior to administration of losartan, or a lower starting dose should be used (see section 4.2). This also applies to children 6 to 18 years of age.
Electrolyte imbalances
Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed. In a clinical study conducted in type 2 diabetic patients with nephropathy, the incidence of hyperkalemia was higher in the group treated with losartan as compared to the placebo group (see section 4.8). Therefore, the plasma concentrations of potassium as well as creatinine clearance values should be closely monitored, especially patients with heart failure and a creatinine clearance between 30-50 ml/ min should be closely monitored.
The concomitant use of potassium sparing diuretics, potassium supplements, potassium- containing salt substitutes, or other drugs that may increase serum potassium (e.g., trimethoprim-containing products) with losartan is not recommended (see section 4.5).
Hepatic Impairment
Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment. There is no therapeutic experience with losartan in patients with severe hepatic impairment. Therefore losartan must not be administered in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Losartan is not recommended in children with hepatic impairment (see section 4.2).
Renal Impairment
As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported (in particular, in patients whose renal function is dependent on the rennin-angiotensin-aldosterone system such as those with severe cardiac insufficiency or pre-existing renal dysfunction). As with other medicinal products that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon discontinuation of therapy. Losartan should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Use in paediatric patients with renal impairment
Losartan is not recommended in children with glomerular filtration rate < 30 ml/ min/ 1.73 m2 as no data are available (see section 4.2).
Renal function should be regularly monitored during treatment with losartan as it may deteriorate. This applies particularly when losartan is given in the presence of other conditions (fever, dehydration) likely to impair renal function.
Concomitant use of losartan and ACE-inhibitors has shown to impair renal function. Therefore, concomitant use is not recommended (see section 4.5).
Renal transplantation
There is no experience in patients with recent kidney transplantation.
Primary hyperaldosteronism
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore, the use of Losartan tablets is not recommended.
Coronary heart disease and cerebrovascular disease
As with any antihypertensive agents, excessive blood pressure decrease in patients with ischaemic cardiovascular and cerebrovascular disease could result in a myocardial infarction or stroke.
Heart failure
In patients with heart failure, with or without renal impairment, there is - as with other medicinal products acting on the renin-angiotensin system - a risk of severe arterial hypotension, and (often acute) renal impairment.
There is no sufficient therapeutic experience with losartan in patients with heart failure and concomitant severe renal impairment, in patients with severe heart failure (NYHA class IV) as well as in patients with heart failure and symptomatic life threatening cardiac arrhythmias. Therefore, losartan should be used with caution in these patient groups. The combination of losartan with a beta-blocker should be used with caution (see section 5.1).
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Excipients
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pregnancy
Losartan should not be initiated during pregnancy. Unless continued losartan therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with losartan should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Other warnings and precautions
As observed for angiotensin converting enzyme inhibitors, losartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockage of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
If dual blockage therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
4.5 Interaction with other medicinal products and other forms of interaction
Other antihypertensive agents may increase the hypotensive action of losartan. Concomitant use with other substances which may induce hypotension as an adverse reaction (like tricyclic antidepressants, antipsychotics, baclofen, and amifostine) may increase the risk of hypotension.
Losartan is predominantly metabolised by cytochrome P450 (CYP) 2C9 to the active carboxy-acid metabolite. In a clinical trial it was found that fluconazole (inhibitor of CYP2C9) decreases the exposure to the active metabolite by approximately 50%. It was found that concomitant treatment of losartan with rifampicin (inducer of metabolism enzymes) gave a 40% reduction in plasma concentration of the active metabolite. The clinical relevance of this effect is unknown. No difference in exposure was found with concomitant treatment with fluvastatin (weak inhibitor of CYP2C9).
As with other medicinal products that block angiotensin II or its effects, concomitant use of other medicinal products which retain potassium (e.g. potassium-sparing diuretics: amiloride, triamterene, spironolactone) or may increase potassium levels (e.g. heparin, trimethoprim-containing products), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. Co-medication is not advisable.
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. Very rare cases have also been reported with angiotensin II receptor antagonists. Co-administration of lithium and losartan should be undertaken with caution. If this combination proves essential, serum lithium level monitoring is recommended during concomitant use.
When angiotensin II antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid at anti-inflammatory doses and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Concomitant use of angiotensin II antagonists or diuretics and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
4.6 Fertility, pregnancy and lactation
Pregnancy
The use of losartan is not recommended during the first trimester of pregnancy (see section 4.4). The use of losartan is contraindicated during the 2nd and 3rd trimester of pregnancy (see sections 4.3 and 4.4).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of medicinal products. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with losartan should be stopped immediately and, if appropriate, alternative therapy should be started.
Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see also 5.3). Should exposure to losartan have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken losartan should be closely observed for hypotension (see also sections 4.3 and 4.4).
Breastfeeding
Because no information is available regarding the use of losartan during breastfeeding, losartan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a new-born or preterm infant.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, when driving vehicles or operating machines it must be borne in mind that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, in particular during initiation of treatment or when the dose is increased.
4.8 Undesirable effects
Losartan has been evaluated in clinical studies as follows:
• in a controlled clinical trial in >3000 adult patients 18 years of age and older for essential hypertension
• in a controlled clinical trial in 177 hypertensive paediatric patients 6 to 16 years of age
• in a controlled clinical trial in >9000 hypertensive patients 55 to 80 years of age with left ventricular hypertrophy (see LIFE Study, section 5.1)
• in a controlled clinical trial in >7700 adult patients with chronic heart failure (see ELITE I, ELITE II, and HEAAL study, section 5.1)
• in a controlled clinical trial in >1500 type 2 diabetic patients 31 years of age and older with proteinuria (see RENAAL study, section 5.1).
In these clinical trials, the most common adverse event was dizziness.
The frequency of adverse reactions listed below is defined using the following convention:
very common (≥ 1/10); common (≥ 1/100, to < 1/10); uncommon (≥ 1/1,000, to < 1/100); rare (≥ 1/10,000, to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Table 1. The frequency of adverse reactions identified from placebo-controlled clinical studies and post marketing experience
So what? The business deal is done in Dollars...
They already are in bed together!!!
Or should I say They already are in bead together!!!
I found a Pearl (I think).
Tell me what are the chances a DEXCEL document from June 2021 mentions ELITE 1 and ELITE 2 studies if they were not partnering already in research?
https://www.medicines.org.uk/emc/product/9045/smpc#gref
we can do 4 cents today...
They do not want LCI to react...
Does anyone have experience with floor price and profit split?
What would be a good scenario to explainer the mechanics of it.
Thanks
I checked on dexcel yesterday and the company has deep pockets.
It invested in several companies in the past.
I see dexcel as a good replacement for sungen.
The next N D A will come from dexcel and elite as partners.
Nasrat has always liked private companies with cash. Epic, sungen and now dexcel.
The 8-k says adderall in israel not worldwide by the way. But this could just be a test for dexcel. If Nasrat delivers they may expand the scope.
Strategic Investments
Dexcel Pharma makes selective strategic
investments in biopharma companies with
complementary strategies and unique approach
to innovation in our industry
I can see Dexcel replacing Sungen as a partner...
I like this page:
https://dexcel.com/dexcel-in-numbers/
Company Profile
Dexcel Pharma is Israel’s largest private pharmaceutical
company. Founded in 1968, we develop, manufacture
and market value-added branded and generic
pharmaceuticals. With a diverse product portfolio that
spans more than 85 branded and generic products in
over 175 dosage forms, our products are sold in the US,
the UK and Germany, via subsidiaries and through a
trusted network of partners in more than 30 countries worldwide.
Dexcell is an international company with up to 1000 employees - they can sell adderall to the rest of the world
This conspiration theory was addressed in one of the Elite quarterly meeting - by killing that possibility Nasrat became liable for a potential lawsuit if he was to do that.
I would not worry about that.
He will benefit like us from a higher PPS.
Who is maintaining the table of the products sold in this Page?
Please add Drexell.. Thanks
No Need - I sent her an email - let's wait for the response.
Thanks
Send her an email - ask her the question - she is very responsive...
For a first time in a long time I feel the stock is behaving normally.
News-> up!
The adderall Israeli market is big. Every kid in israel takes it.
Thank you for buying at 0.039
I think the bad guys got covid or are on vacation
I noticed that in the last few days the stock goes up because the size of the bid/ask which is smaller than before....
This provides also a higher volume.
The stock has low volume when we see 120K, or 200K + size
How many shares do you have?
Are you closing on Nasrat? #2 shareholder?
I like your posts - but I like truth too - 1.2% of shares are held by institutions
I do not see form 4's on the SEC site...
So I think it is several hedge funds or kids in remote locations that are buying low of the day and selling high of teh day.
AELmTPa - you are buying at the best time of the year so far...
Good Luck !!! I bought some recently too.
This is just not acceptable - SEC - Wake up !!!
I forgot that Lannett ceo is an anda collector
$0.04 is achievable today !!!
namtae - he got what we got... people are looking at Nasrat as if he was the devil.
The guy has more shares than anyone else.
think that when the stock goes down by $0.01 cent he loses $2.2 Million...
When there is a movement of $0.001 cent it is $220,000 for him...
His interest is that the price goes up - not down...