RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Thank youI agree the data with or without holes haven't changed they got the go a head for straight phase 3 but they need to adjust the proposed protocol or maybe they need to adjust it to get EMA on board too as there was an agreement between two agencies few years ago so they could align their strategies.
It's not lousy data it's lousy marketing efforts for years which is the issue. It almost seems like the company has lost the confidence re their marketing ability thus they struck the deal and now hoping for positive results to translate to higher valuation.
palinc2000 wrote: Those research articles that you posted are very helpful and again why would the Kol s reccommend spending tens of millions in a trial if in fact there is a gaping hole,,,,They made a lousy deal and even an extremely lousy deal but IT IS NOT BECAUSE THERE IS A GAPING HOLE IN THE DATA.....
scarlet1967 wrote: I posted a couple of research articles published in 2021 emphasizing the role of insulin resistance, mitochondrial dysfunction, pro inflammatory proteins and adipose tissue in causation of NAFLD/NASH quite inline with company's proposed MOA of their protocol and they proved that on HIV liver which because of the virus and ART drugs has more fat deposition than normal liver so the holes might not be as sizeable as some suggested on the contrary the industry is moving away from fibrosis resolution to Nash score reduction as the anti fibrotic approaches have failed miserably to date.Just listen to discussions the KOLs had after FDA,s podcast last Friday, to me it sounded they want to move away from biopsies to none invasive methods and most are not happy with the current endpoints.
palinc2000 wrote: Whatever hole there is we know it is NOT a sink hole....I have not seen any subsequent studies since the decision to go for General Nash which has shown a worsening of the odds of success,,,On the contrary !!!!!
The decision was based on strong recommandations by Grinspoon and lLoomba and probably others .....They know what they have and they know what they dont have,,,,Why would they spend tens of millions if the data is so bad to start with....,,,,,
quote=scarlet1967]Paul said he is going to accelerate the process even so Jim doesn't agreed with me what I heard was he described the dosing and early data as upcoming milestones so my take is they will announce any progress as soon as possible now exactly when nobody knows not even the company but I am pretty sure they are eager to announce early news.
As per holes for NASH we can speculate the size of them and how much the valuation should be discounted but not to allocate any NPV to a phase 3 trial is not the way market values other R&D companies.
The problem is not the hole of the trial the problem is the massive hole in their marketing of the trial.
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