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Great job Mani. Although if the new Phase III trial is as big as the previous trials then it will be 18-30 months before its finished. No chance Traumakine will be approved this year or even 2021 in my opinion. And then of course it only works in 33% of patients who have the right genotype. Note there is no mention of another Japanese trial.....so will never be launched in Asia.
Watch out Z is being economical with the truth again. Lumateperone was trialed in two Phase III trials for two different diseases. It failed one in bipolor depression and passed the other in Schizophrenia. And thus it has been approved for Schizophrenia only.
Traumakine failed two phase III trials for ARDS. And yes they think they know why it failed, but they will have to do another brand new Phase III trial to prove it. Which is going to take years. It has to be statistically significantly different from the placebo in its primary outcome measure that has to be agreed with the FDA before the trial starts. Again look how long the previous trials took to complete....the European trial took over 2 years. Traumakine is years away from being a drug on the market.
A Phase III trial will take much longer than a few months. If you search for Faron's previous Phase III European trial with Traumakine ( Clin Trial ID NCT02622724) you will see that it was started December 28 2015 and completed May 17th 2018. They can't take just any old ARDS patients there are inclusion and exclusion criteria. Again look up the details of the trial and they list all the various criteria. Just search NCT02622724.
"Among the nine subjects dosed so far, across three clinical trial sites in Finland and the UK, two subjects have shown clinical anti-cancer responses". So the Clevegen did not work in 78% of patients trialed so far? Good luck trying to take that to Phase III trial!!
Good news that the drug is well tolerated, and that the relevant biomarkers showed the appropriate changed. However if the drug does not work in nearly 80% patients then they have an issue. Marku has indicated that it may be used in combination with other drugs. Looks highly likely that this will be essential for the Phase III trial.
Now now Mani don't let the science and proper statistical analysis get in the way of a good story! It does make me think at what p value Faron would say the results were not different! p=0.1......p=0.2?!?
Also can you imagine standing up at a conference, submitting to a peer reviewed journal or the FDA and saying "Yes, i know the results are not statistically significant however we believe they back up what we are saying". Oh well that's alright then. Absolutely hilarious to be honest. Faron have now lost all scientific credibility and there is no way the FDA will accept this study, IMHO of course.
Thank you Mani - thought I was going mad!! It's outrageous what Faron have stated in the RNS. I have emailed investor relations to say that they must correct. The n numbers for the groups are small as well so they cannot justify using a higher p value.
I can't believe that as scientists they are ok with the RNS. The stats are saying that there is a very good probability that these results could have happened by chance!!
Sorry Zen, if you don't understand. These are potential drugs that are currently in clinical trials for ARDS. Mani mentioned that other drugs were currently in trials for ARDS in the post below so I found the ones mentioned. There may be more of course so the list is not necessarily complete.
Is there anything else I can help you with?
Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS. Phase IIa at December 2018
Safety and Preliminary Efficacy of Sequential Multiple Ascending Doses of Solnatide to Treat Pulmonary Permeability Oedema in Patients With Moderate-to-severe ARDS. In Phase IIb at April 2019.
Found these two - there are others but they are not small molecules but relate to different ventilator strategies and also administering things like carbon monoxide that I am assuming you will not be able to patent!
Hi Dan,
Yes it is so much harder to bring a drug to market now for multiple reasons completely agree. However big pharma have many drug programs and will often cull them in preclinical research or less likely in clinical trials...Faron have..well you can count them on one hand. Believe me they have some decent science, but with Traumakine with unresolved issues and Clevegen a long way away from making it.... they are a long shot...in my opinion.
Apologies if I didn't answer your question re the sub groups for Traumakine. Do you disagree that the market is now much smaller for Traumakine? Sorry can't remember where we got to.
Zen, did say that I sold my small holding the other day. But I will continue to follow Faron and write on the this board as they have some cool science and would love to see a drug work for some ARDS patients at least.
The issues with Traumakine have not been addressed, they have a good idea and some data to back this up, However this hypothesis must be proved and hence why a new Phase III trial is required. Until the results from the new Phase III trial have come back positive then that's all we can say. Question - why did Traumakine produce positive results in both Phase II trials even when steroids were administered to the patients as well? One reason is that a small a number of patients can give a false positive for a new drug and thus why the FDA make companies do much larger numbers in Phase III trials. Also even if it passes Phase III getting FDA approval can still be tough...just look at Motif with Iclaprim.
Working for a large pharma we once tested a novel anti inflammatory drug in a preclinical model of inflammation. The drug was to be potentially an in-licensing opportunity. First experiment it worked amazing..better than anything we had seen before. So we tested a second time just to confirm results and add a couple of dose groups. This time it was no different to the placebo. Tested a third time and again same efficacy as placebo. Science can throw up well weird results some time. Who knows what the new Phase III trial will show.
Clevegen has shown some really interesting initial results in 5 patients. However when you look at the data from the latest presentation (Zen kindly posted the link earlier) there are no placebo patients to compare it with. Also the data is presented as the mean of 5 patients....with no standard deviations or SEMs. So we have no idea on how variable the data is. One patient might have reacted way more than the others and pulled the mean response up. My point is that this is really early in the discovery process and statistically Clevegen is more likely to fail than make it as a drug at this stage of the drug discovery process.
Zen et al I love your enthusiasm but in my opinion the odds are stacked against Faron. If your happy with this then great, but it's important that new investors are aware.
Faron have no idea they have fixed the problem Zen until they complete another Phase III trial and the results come back as statistically significant compared to the placebo. Traumakine is at least 2 years away from making it to market and that is if it actually works this time around having already failed 2 large Phase III trials. This time it will be harder to recruit patients onto the trial as they will want ARDS patients not on steroids and also ones that have the particular genetic back ground which is present in only 30-40% Caucasians, this will add significantly more time.
Clevegen is looking very interesting....but that is all!! It has been administered to less than a hand full of patients and again is years away from becoming a useful oncology drug. It has not completed Phase II let alone a Phase III trial. Realistically 3-4 years away from being successful drug and then it will be for specific cancers and scenarios.
And Faron may want an up front fee, but that does not mean that big Pharma will give it to them.
And thus I am out. Sold up and broke even, no more and no less. I really hope this does all work out for Faron and all the holders on here, but now this is no more than a very speculative long shot.
Ignore them all Mani. Your balanced views are one of the few reasons I drop by this board. I rarely post now as it's clear the majority on here have virtually no experience of bringing a new molecule to market and do not understand how pharmaceutical companies manage the drug pipeline. Let them wallow in their ignorance.
And if you could let me know about your "Kiwi Life" I would be most interested.