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Last post: Jimmyg1, 20 Jun 2024 18:46
Sorry thought you were talking about tlsa.
Sorry
11th of June 2024
I notice on stocktwits that someone has been trying to contact the company since May. Still had no response by the seem of things. If anyone from BOD or Investor relations is reading this, can you have the common courtesy to update shareholders about this? Are you bust? Are you bought out? Are you fundraising ? Are you even still active?
Even a 2 minute interview or something for goodness say this is ludicrous
Started: BoNidel, 12 Jun 2024 22:10
Last post: BoNidel, 12 Jun 2024 22:10
Didn’t even do the 10 days did it?
Started: snooker1000, 10 May 2024 14:52
Last post: D-Geeman, 12 Jun 2024 13:39
FDA Accepts Tiziana Life Sciences Fast Track Designation Submission for Treatment of Multiple Sclerosis
11th June 2024
NEW YORK, June 11, 2024 – Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA). .
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate shown to cause T regulatory (Treg) cell induction when dosed intranasally. At present, ten (10) na-SPMS patients have been dosed in an Intermediate-Sized Patient Population Expanded Access (ISPPEA) Program with clinically meaningful reduction in fatigue scores (MFIS) in 70% of patients, and stability of disease noted within six months in all ten patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, double-blind randomized, placebo-controlled, multicenter trial in patients with na-SPMS (NCT06292923). The Fast Track Designation request provided data from both animal models and clinical experience from the ISPPEA program. Foralumab would be the only intranasal monoclonal antibody designated as other Multiple Sclerosis monoclonal antibody therapies require intravenous or subcutaneous dosing. Fast Track Designation, if granted will affirm the serious disease condition and progressive disability seen in na-SPMS, and also the unmet medical need, as no therapies are currently approved for na-SPMS.
“Fast track is designed to expedite the review of drugs in development to treat serious conditions for which there are limited or no therapies,” commented Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences. “The progressive nature of na-SPMS and lack of FDA-approved therapies for this disease aligns with the Food and Drug Administration’s criteria for Fast Track Designation. The increased interaction and partnership with the FDA afforded by this designation would be a tremendous asset to our foralumab development program, if granted,” he added.
About FDA Fast Track Designation
At this stage of development, a drug that receives Fast Track designation is eligible for some or all of the following[1]:
More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
The magic $ has now been reached, hopefully will climb further and hold. If Orphan is granted then this might be the beginning of further use of mab's within Tils pipeline. The future potentially looks much more positive and you never know we may just get our stake back!!
This orphan drug status in us could be a huge milestone...the announcement should be within 90 days from early may. Fingers crossed they get it as signs are that it works well for the ms cohort they are targeting.
SP finished on $1, the first time it’s done that in some time. Needs to hold above $1 now to retain its Nasdaq listing. Good to see some positive momentum in the past few weeks though
We been watching and waiting a long time any chance this share ever go up ? When we ever get our money back ?
Started: BoNidel, 5 Jun 2024 23:17
Last post: BoNidel, 5 Jun 2024 23:17
Who knows. I have a shed load of them and won’t be shaken until we find out. No comms for close to a year now
Started: Jimmyg1, 2 Jun 2024 18:43
Last post: Jimmyg1, 3 Jun 2024 20:49
Personalise (psnl) is up roughly 10% at 8:45 bst 3/6/24 acut down roughly 25% but acut has been doing big swings this past month or so. I guess the only way to find out if this has effected us is to wait and see
I wonder what tomorrow's markets will make of this
Has gabriele cerrone missed the boat with all his messing moving from one market to another.
A us company called personalise has just announced at the American society of clinical oncology in Chicago today that they have developed a blood test that can detect if breast cancer will return to a person that has had it and it's 100 per cent accurate.
I found this on the Internet today on yahoo by the telegraph with the name
Michael searles attached to it.
As allways do your own research
Started: BoNidel, 23 May 2024 22:28
Last post: Jimmyg1, 31 May 2024 15:01
Can't see It holding It done that on 602 volume plus it done that about a week ago as well on no news and no volume
AccuStem Sciences, Inc. (ACUT)
0.4700+0.1930 (+69.6751%)
At close: May 30 02:10PM EDT
Would be nice if it holds.
Won’t be long and it’s a year before anything meaningful.
Started: DD77, 13 May 2024 14:14
Last post: Jimmyg1, 30 May 2024 08:08
Creeping up to the dollar nicely. As allways pharmacy shares very slow to move but on a constant flow of good news and catching the eye of bigger pharmacy.s who knows what may happen
Seems to be some welcome movement... questionable if will be sustained...but will hold what I have left for now
As for accustem tis a shambles
90 days time (or earlier) could be a inflection point. Here's hoping
Https://www.nasdaq.com/press-release/tiziana-life-sciences-files-for-orphan-drug-designation-for-intranasal-foralumab-2024
Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has submitted an FDA request to obtain Orphan Drug Designation for intranasal foralumab for the treatment of non-active secondary progressive Multiple Sclerosis (na-SPMS). This request would make foralumab the first therapy for na-SPMS to receive Orphan Drug Designation. Our request is supported by clinical and non-clinical evidence of Foralumab’s effectiveness in na-SPMS. The prevalence estimates, in part, are supported from the Brigham & Women’s Hospital, Boston, Massachusetts, longitudinal study, the CLIMB data of which allowed the estimate of na-SPMS in the population.
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally.[1] At present, 10 patients with na-SPMS have been dosed in an open-label intermediate-size Expanded Access (EA) Program with an additional 20 patients recently allowed to enter the program by the FDA. All patients in this expanded access program have either improved or stabilized on treatment with foralumab. 70% of patients have seen an improvement in fatigue after six months of treatment. Fatigue is a debilitating symptom for many MS patients and is measured by the Modified Fatigue Impact Scale (MFIS). None of the patients have declined in key clinical measures. In addition, intranasal foralumab is being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial (NCT06292923) with a data readout planned for 2025.
“Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the U.S.,” commented Gabriele Cerrone, Chairman, acting CEO, and founder of Tiziana Life Sciences. “Orphan Drug Designation allows for up to seven years of marketing exclusivity if the product is ultimately approved for its designated indication, as well as providing the opportunity for other financial incentives to assist with development. It therefore carries significant value to our company and shareholders,” he concluded.
Once submitted, applications are reviewed by the FDA’s Orphan Drug Designation program, which determines whether all criteria for Orphan Drug Designation approval have been met. Applications are reviewed by the Orphan Drug Designation program within 90 days of receipt.
Started: BoNidel, 20 May 2024 22:37
Last post: BoNidel, 20 May 2024 22:37
Submitted today, covers up to March. They had $9k dollars left. How are they even functioning?
Are the directors just not taking their salaries? What’s happening here?…
Started: Biginersguide, 18 Apr 2024 16:54
Last post: 2seabass, 26 Apr 2024 17:00
It appears formulab is on the cusp of much larger trials once the expanded (30)..... which are looking likely to be successful on completion. It also appears this treatment works for many inflammatory conditions
With the patented drug delivery we may get a surprise, but we need to get past the next fundraising first!!
Possibly so, I'm also unsure what to make of it. The SP reaction continues to be positive, up to 86c today. Still a long way off the levels most have bought at, and still below the $1 threshold for NASDAQ holdings.............but it seems to have momentum and perhaps something will come of it
Not really sure how to rate this news. On a scale of 10 I would say 6/10? Its good but not very good.
I can only see big rewards for us holders if TLSA partners with a major pharma to develop foralumab.
Released today on most big news sites
As a LTH . I have watched the share price drift lower on no news and low volumes
recently we have had some very promising news on developments and much higher volumes as the share price rises
I take this to be a good sign as (hopefully) institutional investors come on board
In any case I see this company being bankrolled by our founder and with his many successes in BIO, i expect a buy out of the company within a couple of years, by which time the price will be multiples higher
Long term hold
GLA
Started: milnrowmug, 16 Apr 2024 21:13
Last post: D-Geeman, 22 Apr 2024 15:00
Tweet on X;
‘ Today We Have Announced 70% of Patients in the Non-Active Secondary Progressive Multiple Sclerosis Expanded Access Program Have Seen Measurable Clinical Improvement in Their Fatigue After Six Months of Treatment with Nasal Foralumab. All Patients Have Either Stabilized or Improved and No Patients Declined in Key Clinical Measures. $TLSA
In the below table we show either an improvement or stabilization in these key clinical measures.
— Denotes stabilization ↓ Denotes improvement
#MultipleSclerosis #MS #SPMS #PIRA #SmoulderingMS ir.tizianalifesciences.com/news-releases/…
SP flying today, up to 72c. I know they were doing a presentation, so i presume this is on the back of that. Looks promising, unlike Accustem. I don't even know if i'd be able to sell the paltry amount of Accustem shares i have, i imagine they're very illiquid
Up to 58¢ today, was 42¢ recently and over 80¢ a few months back. Accustem aside, wtf is going on here, anyone?
Started: BoNidel, 10 Apr 2024 19:44
Last post: BoNidel, 10 Apr 2024 19:44
What’s going on FFS
Last post: hankscorpio1, 5 Apr 2024 19:55
Still hold some free Accustem shares from the Tils meger back in 2020. Not been keeping up with whats happening. Do we see Accumstem running out of cash and winding up or there any chance the SP can move in the right direction?
Thats the MCAP then
“ As of December 31, 2023, our cash balance is $21,481 which is not adequate for our current planned level of operations, through at least April 2024.”
Taken from the recent 10K filed on 22nd March 2024 covering up to Dec 2023.
Started: BoNidel, 25 Mar 2024 19:59
Last post: BoNidel, 25 Mar 2024 19:59
?
Started: BoNidel, 22 Mar 2024 14:05
Last post: BoNidel, 22 Mar 2024 14:05
@ current bid of 0.365 dollars you’re buying around 3 accustem shares for £1 sterling.
To have 3 accustem shares at the current consolidated level you would have had to have I believe 60 Tiziana shares at EX date in October 2020 which were around £1.80 per share. So, if I’m right,
£1 of accustem shares now buys you around £108 worth of accustem shares in October 2020 (or tils shares you had to hold for the entitlement).
MCAP is currently around $4m USD so circa £3.2m sterling.
Is this a wild bargain or an absolute waste.
How are they still operating when they only had like $70k cash in September or something and their burn rate was say $60k a month?
Does anyone want to update shareholders as to what is happen? Is accustem still trading?
What the hell is going on? They said they would be presenting data in January wasn’t it? No updates, share price destroyed, no cash and no comments
Started: BoNidel, 18 Mar 2024 20:44
Last post: BoNidel, 18 Mar 2024 20:44
Ex date was 4 years ago this year.
Any updates? Paul the plumber is there any update with accustem? Aren’t you doing PR there now?
Started: BoNidel, 1 Mar 2024 20:54
Last post: BoNidel, 1 Mar 2024 20:54
No updates since what last June or something ?
Started: samplemix1962, 29 Feb 2024 18:04
Last post: samplemix1962, 29 Feb 2024 18:04
So they moved from AIM to the Nasdaq and it just keeps tanking despite all the news updates.
Started: BoNidel, 20 Feb 2024 23:00
Last post: BoNidel, 20 Feb 2024 23:00
7th June 2023 was the interview with proactive investors, over 8 months now and no update on commercialisation or the university hospital collab outcome.
Sick of this.
Started: BoNidel, 14 Feb 2024 17:30
Last post: BoNidel, 14 Feb 2024 17:30
Someone on stocktwits is feeling the same as me RE accustem. How are they still functioning with no cash
Started: BoNidel, 9 Feb 2024 23:48
Last post: BoNidel, 9 Feb 2024 23:48
Where’s the PR GUY? It’s 10% of the way through 2024 now and no accustem updates
Started: cajan, 9 Feb 2024 09:52
Last post: D-Geeman, 9 Feb 2024 19:49
'At last after 28 months'
Bl**dy traders ruining this share!
At last after 28 months. I was just preparing to provide the Ombudsman with documents from my complaint !!
My Barclays account is quoting TILS in USA dollars and showing them as sellable this morning!
Is the plumber/PR guy still ramping on these boards ?
Is there an update on accustem ?
Is Tiziana staying on Nasdaq ?
What happened to the accustem university hospital data sets?
How are accustem funding operations.
WHAT IS HAPPENING?
1133 days since the accustem ex date,
4 years this year and no uplisting. I know biotech has been in a bear market but why not update regular long term holders ?
It just stinks.
Started: BoNidel, 6 Feb 2024 10:38
Last post: BoNidel, 6 Feb 2024 10:38
No updates on accustem.
What a load of old cobblers. Into our 4th year now
Started: BoNidel, 31 Jan 2024 15:29
Last post: BoNidel, 31 Jan 2024 15:29
?