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https://www.medrxiv.org/content/10.1101/2020.04.01.20049700v2.full.pdf
Interesting bit of info here. I found this pdf which is dated 01.04.2020 . It is the post hoc analysis of the INTEREST trial posted on by Faron on MedArchive which is a free site for med/ science papers which have not been peer reviewed but are deemed worthy of public dissemination. MedArchive was set up last July by Cold Spring Harbour / BMJ publications and Yale, so it has serious credentials. Although the work was done some time ago it is upto date as the corona virus pandemic is mentioned in the conclusion. Whatever your view of post hoc analysis I believe this is a positive move from Faron, although they haven’t publicised the submission to Medarchive in any way it is a full and very thorough scientific analysis. It shows Faron are prepared to stand up and put their data in the public realm, explain their rationale re steroid interference and invite discussion.
Thanks everyone for your comments and SAX I will take you up on that offer!
No matter what your allegiance , the REMAP trial is an unprecedented opportunity to finally put to bed the question of whether Traumakine is effective against ARDS in the absence of steroids. Since it is an adaptive protocol there are some real plus points over a conventional phase 3 – positive results are released far sooner and patients can be directed onto the more efficacious treatments actually during the trial. In conventional phase 3 the flow of info is very limited, until the final report is released. Basically the DMC will stop the trial if a higher death rate occurs but apart from that they usually recommend proceeding as per the protocol, giving no clue re efficacy. This trial actually bypasses the FDA approved CALIBER part 1 /11 trial as the results will be known – and actioned on, far sooner. The REMAP trial has no far eastern recruitment so no issues re non responding genotypes from that part of the world. The issues FARON need to nail down right from the start are 1) Getting the right patients on Traumakine, they have 550 recruited now so approx. 6500 eligible going forward. . About 2220 could have the correct genotype for response ( but probably a bit less as people of far eastern origin will be on the trial in Europe etc ) , so still plenty to go at. This is a large complex trial- since Faron are not running the trial –just suppling drug plus expertise, they need to make sure no one gets treated without having the right genotype. This is the real essence of the emerging personalised medicine revolution- correct stratification of patients before therapy is given. SNP-genotyping is just everyday diagnostics these days, so should not be an issue.
11) Supply of Traumakine- Faron have plenty of stock but personally I would get a new supplier on board and put an RNS out asap- it would show they really do believe a lot more will be required. The issue with Rentschler is a non event- Faron may as well sue since they have nothing to lose but getting another supplier if Rentschler want out is no problem- they’ve maybe done this already ?
The crucial issue now is time- or lack of it- how quickly can Faron be integrated into the trial ?
Again other questions are raised – would this influence Fimea? Will compassionate use get revisited by clinicians who have been cautious up to now. Would it speed up signing a partner, or would a partner now hold back on the FDA trial , and sign a deal based on REMAP data? Maybe more than one partner would emerge ? Will the normal routes to approval be radically altered due to the Covid 19 pandemic and could real world treatment of ARDS patients begin based on results whilst the trial is still running?
Questions! I am invested at £ 7 so if it goes past that I am going to let out a massive sigh of relief.
One certainty is we are now going to know the answers a damn sight sooner than waiting for the CALIBER trial to grind to completion.
The recent RNS was interesting- and encouraging- but it actually posed as many questions as it answered.
I would like to know the design of the INTEGRITY trial and the biological question it is designed to answer- this would at least shed some light on the thought process of the FDA It appears to be a YODA style trial to be run on healthy volunteers to aid the CALIBER trial design. Possibly the reason for demanding more data relates back to the original YODA trial?
The analysis carried out to determine if there was any difference in CD73 ( a key protein involved in lung function ) levels between volunteers given Traumakine alone and Traumakine plus steroid did not show a significant difference- in statistical terms, despite the fact Faron confidently presented the data as supporting their theory re steroid interference.
IF Faron chose to submit this data – ( maybe they didn’t, but it is in the public domain anyway) as supporting the application I know for certain the FDA would have taken a good hard look at the statistics and also the information that the 2 groups only comprised 12 combination ( Traumakine and steroid) and 10 Traumakine alone, volunteers. These groups are too small to produce an unequivocal result either way - maybe the FDA decided to play hardball and asked for the numbers to be increased? It really is impossible to say, until the design rationale is clear.
You could also speculate as to why Faron split the original design into 2 distinct segments- did the FDA advise this or was it done to lessen the cost to entry for potential partners, or another reason ?
This decision though creates another hurdle to pass before approval might land. The INTEGRITY trial could take up to nine months to complete ( or more depending on the cohort specified) even with funding and a Traumakine supplier signed up , so about 2.5- 3 years to registration all told, if no setbacks occur.
The FDA are supportive of novel treatments for unmet needs but they are definitely not in the business of allowing therapies to be let loose on the population which haven’t been through an extremely stringent regulatory process. If they were, we would be back in the days of snake oil salesmen when toxic and useless garbage was sold to desperately ill people for pure profit. Therefore any talk of ‘straight to market’ is ludicrous. Faron believe they know why the INTEREST trial failed but the final arbiter will be the FDA. The take home message is that pharmaceutical development and market approval is a long incremental expensive slog, and not a get rich quick scenario- anybody who thinks otherwise is in for a disappointment. Hopefully the funding will soon be in place, CRO negotiations completed and recruitment get underway asap.
It is the same in the USA-historical Fast Track, BreakThrough designations etc. are irrelevant if you are not now in phase 111 and generating supporting data.
The Faron website redesign has buried the fact that Traumakine Interest trial failed to meet the criteria for efficacy- the RNS is still there but you have to delve back to find it. This is of course what any early stage company such as Faron has to do, ie. - focus on the positive but put negatives well into the background.
Faron has done some good work data mining the subsets and building up a picture which suggests there is a subgroup of responders with a particular genotype. However they concurrently discovered that only 10 % of the far eastern population have this genotype – which knocked the Japanese partner out of the picture- and that only a third of the Caucasian population will benefit- smaller numbers but still enough for commercial success. The problem with post hoc analysis- ie after the results are known is that the FDA takes a dim view of it-( another name for it is data dredging ) which is possibly why they are still asking Faron to re jig the application for consideration , rather than just rubber stamping it.
Faron Traumakine Part 1
This post is for the benefit of anybody thinking of investing in Faron , has read the posts on this board and has ended up rather confused as to what the current status is re. the prospects for the company. It is an update to an earlier post from Dec 2017, and mostly concerns Traumakine, and is not a recommendation to either invest, or hold back. Some of these views are not new- they have been made by other posters way back but have been drowned out by a delude of posts which verge between pure conjecture and total misrepresentation of data.
I am invested - in 2017 , not too many shares but obviously in deficit right now. I also work in commercial lifescience and have had a fair bit of exposure to the FDA, EMA and UK regulators ( MHRA) predominately.
Traumakine. – currently awaiting a decision from the FDA giving the go ahead for another phase 3 trial (CD 37 CALIBER Global ) after it failed to meet the endpoint for the Interest trial – reported May 2018.
Traumakine has been granted a ‘promising innovative medicine’ (PIM) designation by the MHRA, ( UK ) but this was in 2017 , when the drug was in phase 3 trials- the next step would have been application for EAMS status- this typically happens towards the end of phase 3 and allows patients access before full approval and of course enables the sponsor – ie Faron to build up a base of experienced clinicians to give the drug a flying start on approval. If EAMS is awarded then the sponsor has to supply the drug free of charge until full approval, so initially it is a drain on resources, but worth it.
Since it was apparent phase 3 was going to fail, EAMS could not be applied for, because it could not be shown that Traumakine was more effective than the current treatments. Unfortunately as it stands the PIM designation is now meaningless – only if Faron is given approval for another phase 3 , and encouraging data is generated will they be able to apply for EAMS approval. EAMS is not a way of bypassing the normal approval route to formal MA either, Traumakine still has to go through a full phase 111 to get to a product licence. Gaining EAMS would definitely send the stock price up though.
Here is the link from GOV.UK https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams
giving an overview of the process. If anybody needs clarification re. the nomenclature I would be happy to assist.
Things have certainly calmed down and become more civilised since Zengah and Gammy were thrown in the stockade for misbehaving. However I think Zengah is good value- he definitely provides all the laughs with his berserk ramping and posting every 5 minutes, maybe we should have a whip round to bail him out early so he can dust himself down and be ready for action first thing Monday morning! Gammy needs a bit more corrective incarceration so Monday week before they let him loose again.....
As an aside, a " highly placed source" reckons Zengah was Tommy , and Esther in an earlier life on this board- both of whom were terminated. Maybe Zengah has been busted for the third time and really is down and out. Zengah , please say" I'LL BE BACK ! " somewhere on the web just to confirm we can all enjoy your optimistic posts once again....
For anyone new to investing just remember, MMs are the Antichist- or if you prefer, a slime mould in human form.
Cynoman, thanks for your comments and input.-points taken.
Note this part fits between parts i and 2
The third and final massive red flag, -the sell off in the days before the May announcement after months of rock steady pricing and low trading. It looks to me like all the people who were involved and could sell out, did . These folks are technicians, researchers, family friends anyone involved in the trials across Europe who had had a small/medium punt and had access – or hearsay to the final report. The big director holders obviously could not sell out . This sell off would never, ever have happened if the trial were a success.
This post is not War and Peace but still too big for 1 post , so I have split it in 2 , read both sections...
For anyone thinking of investing in early stage biopharma here are my thoughts based on my experience with Faron. ( Hindsight is a great thing..)
Note unless mentioned this means Traumakine.
First off- I own a smallish amount of stock bought at over £ 7.00 . So rather in the hole so far. I also work in life science – commercial, but not directly with drug development.
Things to bear in mind-this is a HIGH RISK business.
1) Only about 9% of compounds put into phase 1 ie Tox trials go all the way to approval.
2) BUT compounds which get as far as phase 111 can- depending on who’s stats you believe have approx. a 50 % chance of approval. Whether or not the compound is a commercial success is another matter.
3) Big pharma can absorb these misses- one product outfits cannot -they go bust, ( Renovo) assets get sold in a fire sale or they limp along for years giving no return. ( Circassia, Geron).
Faron was founded on the basis of a compelling but absolutely miniscule trial – one study ,37 patients. An open label trial – ie. the patients know what they are getting- such trials are notorious for the placebo effect. Interferon has a very chequered history- it has been touted as a silver bullet right from the 1970s-as a virus killer, cancer killer etc. but never hit the big time. Good enough data to get the IIs to support an IPO but hellish risky if it’s your hard earned cash.
So back in mid 2017- looks great -fast rally up to~ £ 8.00. Plenty of BOD buying in, constant trickle of positive action and news.
The first red flag was an RNS in August mentioning exploring compassionate use of Traumakine. This initiative was never mentioned again- lets face it-if Traumakine had worked as it did in phase 2 then it saved lives- and this type of usage would have been pushed forward.
Second red flag – back in December 2017, recruitment ended , by now Faron knew the product did not act as expected- ARDS is an acute syndrome- the primary endpoint, as per the original design protocol was 28 day survival but they announced they would include 90 day survival data before publishing results. Totally unnecessary if the results for 28 days were very good. It was proposed by the independent monitoring committee but I would suggest the company pushed for this as well. This was actually a smart commercial move because it allowed time for stock a placing in Feb 2018, well supported as the company was still riding on a high. Without it Faron would be history by now.
Note- the announcement of a second manufacturing site in Feb 2018 meant nothing- it costs virtually zero to contract a commercial supplier to supply X amount of interferon B at some time in the future- however it is the sort of RNS the investors like to see. No physical infra structure gets built .
The third and final massive red flag, -the sell off in the days before th
This post is not War and Peace but still too big for 1 post , so I have split it in 2 , read both sections...
So what are the positives?
1) The board- and others close to them -have put a load of their own cash into Faron. Unless they are all independently wealthy and like a gamble they must truly believe Traumakine( or Clevegen) has a future. Esp J Knowles ( no longer BOD) who bought 63 000 shares in Sept ( 2017) - maybe he wasn’t quite in the loop on the results…. ?It was this trade that overwhelmed any negative vibes I had and kept me in this stock- surely no insider would buy the thick end of half a million pounds of stock this close to the end without knowing something we don’t- or would they …?
2) A possible reason for the unexpected result is being investigated. Note only a POSSIBLE cause.
3) This company is not made up of a bunch of chancers- believe me, I have seen a more than few in Biopharma.
4) Partners are being sought- whatever the outcome here, they won’t pay £ 8 per share for a buy out nor will any deal cause a spike back to £ 8.0. But the company should survive.
5) Anyone buying now might make some return – as maybe rock bottom has been reached.
The downside - it’s going to be a long wait for folks like me, in at the high end.
The Japanese trial will replicate the EU trial – no joy there. If the YODA trial comes up trumps another phase 111 has to be run – so 2-3 years down the line before we get back to £ 8.00. -what it took in the first place. A partner is a must for this to happen.
Re Clevegen -this is firmly in the realms of theoretical immuno- oncology so don’t plan to retire anytime soon on this one.
My own gut feeling is that the original trial was just too small to give a true picture , BUT then again the phase 1/11 in Japan also looked good- albeit with a tiny cohort. So maybe I’m wrong….
Finally- Remember this is not just about making a buck- a hell of a lot of people were placing high hopes on this treatment for a pretty frightening condition- lets hope things get on track.
With no conflict now, will Abcam adopt an aggressive stance re another bid for Horizon , or is that well in the past ?