Proposed Directors of Tirupati Graphite explain why they have requisitioned an GM. Watch the video here.
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Cheers Porter, an excellent and informative interview and very encouraging on prospects and potential going forward. Exciting times ahead. Gl :-)
Interview with Zak Mir:
https://m.youtube.com/watch?v=FJOC1ciauAg
- US fast tracking Nash trials
- 100,000 patients on liver transplant list in US alone
- talk of further US institutions coming in
- delivering Nash treatment like a vaccination - think how much money was made on covid…
You would presume we are at the front of the list!
GLA
Great find Northeast and exciting news for Genflow. Gl :-)
First in human proof-of-concept Phase I/ II Trial in NASH
NASH or Non-Alcoholic Steatohepatitis is a liver disease with a significant unmet medical need. Effecting an estimated 35 million people worldwide, it is the most chronic liver condition in the West and patient numbers are growing rapidly. It is the leading cause of liver transplants due to the lack of approved therapies with the market for NASH therapy expected to reach $27.2B by 2029.
Recent pre-clinical programs have highlighted the adipogenic, anti-fibrotic, and anti-tumoral effects of GF-1002 positioning it as a promising treatment candidate for NASH.
By targeting NASH, Genflow Biosciences stands to benefit from a clear regulatory pathway that could lead to accelerated development and the potential for conditional fast-track approval.
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.
Love how indirectly he calls out the crooks from FLV right at the beginning.
All good here now going forward.
Absolute steal at this price now.
Agree, the directors wouldn’t have committed such a large amount of personal funds if they weren’t confident in their research and what lies ahead. Hopefully now we’re entering a news rich period :)
It's all good and now look forward to a flow if positive news. Gla ;-)
At least we’re back to blue Dave. Now we anxiously await to see who has taken the other shares, TR1 perhaps?
Anyone want own up on the selling front here.
Just ridiculous and what as the point in investing in the first place.
Everything about this company is incredibly positive and it's astonishing that we are so low regarding share price.
Hard to fathom.
Thanks
£715k added to the non dilutive grants. Rare to find a company where the cash exceeds the mcap 👌🏻
No worries will ADD IF SHE DRIFTS IM LONG HERE SO DROPPING TO 1.25 MAKES no difference to me .For me its the end game im interested in .Have a great day all
Tried to buy at 1,5p a few wont let me want 1,58 might have to bite the bullet will try 1.52/4
Not loads but enough for a trade . Seems a decent price but who knows . GLA DIDNT THINK i see under 130 buy op again . Oil is i think 87 talk of going to 100
Genflow Biosciences (LON:GENF) (OTCQB:GENFF)
1,558 followers
7h
The first #NASH treatment is FDA approved! Despite its growing rates, the disease went largely understudied for decades - until now. Genflow Biosciences (LON:GENF) (OTCQB:GENFF) and its peers are developing life saving medicine to change the lives of millions.
Read more: htTps://loom.ly/fYAsZzA
Healthy Returns: The first drug for a common, deadly liver disease is here – and more are coming
PUBLISHED TUE, MAR 19 2024
In a landmark decision on Thursday, the Food and Drug Administration approved Madrigal Pharmaceuticals' drug "Rezdiffra," to be used along with diet and exercise. The company expects the medicine to be available next month with a hefty price tag of $47,400 per year before insurance and other rebates.
The agency's approval is also a big deal because it means Madrigal has succeeded in an area where several other drugmakers have failed – or are still trying to crack.
That gives Madrigal an edge in a market that could be huge: The MASH industry could be worth nearly $26 billion by 2032 across the U.S., France, Germany, Italy, Spain, the U.K. and Japan, according to an estimate from data analytics firm GlobalData.
Madrigal's drug is setting the bar for efficacy and safety for MASH treatment, while also opening the door for medicines still in development.
There's one important detail in the approval that could bode well for the entire MASH space: The FDA isn't requiring patients to get a liver biopsy to determine their eligibility for Madrigal's drug.
That refers to a procedure in which a doctor removes a small piece of liver tissue from a patient so they can examine it under a microscope for signs of damage or disease.
"The absence of liver biopsy requirement in Rezdiffra's label should buoy biotech stocks" of companies developing MASH treatments and "potentially accelerate and broaden patient access," William Blair analyst Andy Hsieh wrote in a note on Friday.
htTps://www.cnbc.com/2024/03/19/healthy-returns-first-nash-liver-disease-drug-is-here-more-coming.html
March 2024 Company Presentation
hTtps://genflowbio.com/wp-content/uploads/2024/03/GenflowBio_Presentation_3-6-24.pdf
That's my plan......On and UP!!! Gla ;-)
That’s it, hold for gold
Kind thanks Northeast14 as you all know with pharma takes time .Not all get there but geneflow has great potential . Where is the bottom who knows . BUT I SUSPECT at these prices we are not far out . No need to keep looking every five mins here as i understand the path ahead here . Good luck all
Money,
The word is the institution are definitely coming! The only way is up.
GLA
Lol, you've got a few more than me Northeast, but i'll be closing the gap tomorrow if all goes to plan. The current rockbottom low sp could be the bargain of the century in the not too distant , with multiple potential opportunities /scenarios to propel Genflow’s value skywards. Gl :-)
Money!
You will be at TR1 soon. Leave some cheap tickets for us please.
Good to see some strong hands entering. There is a telegram group too if anyone wants to join. If you look up #genf on twitter you may be able to find the link as it gets censored here 👌🏻