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Hey Porter, that makes two of us
GL
Can’t believe this isn’t at 2p now. No one interested in selling
Very good past few days
Lovely stuff MONEY! I think there’s maybe less than 25% free float. Saying that a lot of this is with people like us who will be here for the huge returns. All going to get very interesting very soon
Good to see Mr Swann increase his holding! Orders being filled in the background, are premier Miton still buying but now from open market?
Only the beginning!
Great to see strong buying yet again. More shares going into serious investors hands. Free float shrinking as the days pass! Rerate
You would presume we are at the front of the list!
GLA
The European Medicines Agency (EMA) said in a new reflection paper that it will consider granting conditional marketing approval to sponsors developing treatments for non-alcoholic steatohepatitis (NASH) based on the use of intermediate endpoints to address a high unmet need for these products.
The paper addresses non-cirrhotic NASH, fibrosis stage 2 and 3, and cirrhotic NASH (fibrosis stage 4).
EMA said the paper outlines a “preliminary” development strategy for these products, as their experience in this space is still evolving.
EMA said that NASH “is considered the progressive, necro-inflammatory phenotype of non-alcoholic fatty liver disease (NAFLD), which itself is the most prevalent chronic liver disease worldwide with an estimated prevalence in the Western world of around 25%, and it is estimated that about 20-50% of these suffer from NASH.”
Despite the prevalence of the disease, there are no approved treatments for NASH in the EU. In the US, the Food and Drug Administration (FDA) on 14 March approved Madrigal Pharmaceuticals Rezdiffra (resmetirom) for treating adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis).
EMA said that “due to the unmet medical need in the field, a strategy to obtain an early, conditional approval (conditional marketing authorisation; CMA) of new compounds based on these intermediate endpoints could be considered.”
This strategy will only be acceptable if an unmet need is still present, a positive benefit-risk ratio can be concluded, and the applicant can provide comprehensive data post-marketing.
For non-cirrhotic NASH, fibrosis stage 2 and 3, acceptable intermediate endpoints would be:
The resolution of NASH – with the presence of any grade of steatosis, and no ballooning, only minimal (grade 1) lobular inflammation and no worsening of the stage of fibrosis.
The improvement of fibrosis by at least 1 stage without any worsening of NASH, and no worsening of ballooning and lobular inflammation, and no more than 1 grade increase in steatosis.
For cirrhotic NASH, fibrosis stage 4, or compensated cirrhosis, the reversal of cirrhosis can be considered an intermediate endpoint. “The endpoint would need to exclude the occurrence of any decompensation event, an increase in MELD [Model for End-Stage Liver Disease] as well as a deterioration (or re-occurrence) of features of NASH activity (inflammation, ballooning, and fat) at the same time (Improvement of cirrhosis by at least one fibrosis grade without occurrence of a decompensation event and without deterioration of MELD and NAS-score).
The paper will go into effect on 1 October 2024.
That’s it, hold for gold
Money,
The word is the institution are definitely coming! The only way is up.
GLA
Money!
You will be at TR1 soon. Leave some cheap tickets for us please.
Welcome Score!
I have it at roughly 2.5m if buys today. Most showing as sells. Somethings happening maybe another TR1 will show soon.
Money,
My thoughts on this when I read they may look at acquisitions. Genflow will 100% get looked at here. Especially after that paper being released last week re patent! They have everything that big pharma’s need. We have the R&D and the patents to back it. Fantastic!
Virtual investor conference 7th March. Featuring GENFLOW and other US trading company’s in Life Science! Couple of the Big Nasdaq companies also presenting. Some great exposure
Great post Tip.
I’m sure the big dogs are all sniffing around Genflow now. Any leak will see this flying. People are definitely building larges positions.
Absolute Bargain stuff this
Can’t get over the selling. More cash than Mcap. More grants applied for and continues advances in the longevity and NASH fields.
Longevity product to be sold for roughly £10/15k a go!!
All this for 1.5p 🤯
Dr Leire added: “Our treatments are preventative, rather than a cure. We would look to start treating people in their 50s, as age-related diseases tend to start in the 60s.
“It’s envisaged our products would be off the shelf, and patient-friendly, topically administered to the skin or injected via IV. Treatment wouldn’t need to be regular, perhaps every one or two years, at a cost of perhaps £10-£15,000.
And all for 1.6p a share!!!
2024 will be a very busy year!!!