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just for clarification, the FDA has 60 days to OBJECT the NDA sumission and request for priority review. So no news is good news. As Polarean notified the market about a submission (effective, about to be effective ?) on Oct 7th, we should get confirmation any time.
the pieces of the puzzle are falling into place. While glancing through the 30 or so trials referencing polarized xenon 129, I came across that one:
https://clinicaltrials.gov/ct2/show/NCT03884842
Sanofi is not the formal sponsor of the trial, but listed as a collaborator to the trial. They are using the Polarean imaging within a Dupi trial in asthma. Dupi is turning into Sanofi's biggest blockbuster. It was originally approved for atopic dermatitis, but then extended to some forms of asthma. As far as I am aware this is the first time Polarean polarised xenon 129 is being used by a commercial player, not to mention big pharma, to support a commercial product. Not an academic study, not a orphan disease, not an early stage asset. This is very good.
this is absolutely sickening. Who is warming up the April original data with ZERO additional information ? There is no rational in doing that: put up or shut up. This story and everything I have been reading in this chat room for 3 months is such a pile of **** that the world's energy challenge could be solved with methanizing it ! Where is the detailed data ? when will it be presented ? when will management answer direct investors' questions in a conference call ? when will they cut their losses if they don't find a pharma partner and put up the company for sale ? when will they stop pretending they are in control ? when will they wake up to reality ? when will they go ?
not without Valium, which I have unfortunately run out of.
I hold 1% of the share capital, if anybody with enough experience of how to make the BoD's life impossible AND enough shares to help me dictate at least part of the script, please feel free to get in touch, I might reconsider in the future
1 out of 11 deaths specifically attributable to Benlysta, I am not sure this is futile. Confirmed safety profile should be rephrased confirmed toxicity profile: 31% had 1 or more SAE event, 19% grade 3 or 4 !
This is clearly a very positive interim result, absolutely no doubt about it. 2 remarks though 1) small numbers 2) the trick will be the design of the future ph2b trial. The same design is impossible in a blinded placebo controlled trial. Moving up to 1st line is the rational thing to do but that would imply going head to head with the newly approved CDK4/6 inhibitor in that setting. It will be very interesting to see how evgen will handle that challenge: alone, with a partner ? The latest hire, an experienced clinical development lady, shows that they fully realise where the focus has to be going forward. But anyway, the big big prize is SAH, if we see anything there later this year, BINGO. But I have to say, this is high risk, we should not fool ourselves.
gyp8, which one are you refering to in the BMS pipe ? RORgt I suppose. It is the only new target I have some hope for in autoimmune. Not S1P1 (also in lupus by the Actelion spinout) and and even less so in any of the other ones listed there.
Misdiagnosed ? dump that possibility on the spot. SLE is tricky to diagnose in a primary care setting, but once referred to a rheumatologist there is no room for such a mistake any more. Even less so within the scope of clinical trial. SJS and CD had been flagged by the company in the past. 2 years ago SM presented her preclinical work on other indications in London. Some of it has been published in the mean time. Instead of throwing funny ideas in the air and see what happens, could we concentrate on facts ? I for instance object the extravagant compensation of the 3 directors. It’s absolutely insane ! I say that without any hint of provocation, but 1/3 of what they granted themselves would still be more than generous. 260k for TM ? That’s mind blowing ! It’s up from 200k in the previous year ! Should be cut to 50k max. RZ cashes in 494k. Again, outrageous !!!!! Even if he is the one with the highest workload. He is also the largest shareholder of a chronically cash burning company who should be leading by example: 150k max ! CEO DD is on 300k, that’s the biggest mystery of all. What’s his role again ? Commuting between Switzerland and London to optimise his tax situation is one thing, but what does he do for that money ? 100k max. 80% of the share capital is held hostage by this triumvira of self serving, grossly overpaid has been. They have to go. NOW !!!!! That has to be the message at the AGM ! Anybody to join ?
http://www2.cnrs.fr/sites/communique/fichier/cp_lupuzor_vf.pdf
because it was such a sublime PR breakdown, I give it to you, in French. Jaw dropping, even more so in French ! I saved the pdf, so if there is anything else you want me to elaborate between my views and their communication, be my guest, happy to help
Youngharry, I won't comment further thant that on how much value/credit should be attributed to patients blogs, especially in an autimmune disease with a documented placebo above > 40%, but I think that you are mixing up a few things as far as dates are concerned. 1) 35/49 Mauritian patients were ready to go in the summer of 2016, waiting for the admin to be finalised. Sylviane Muller made the trip there to celebrate the opening of the center. 2) As I posted a few months ago, you can infere from the RNS trial updates of treatment completion the speed of recruitment. I estimated at 52 the number of patients randomized 15th Sep 2016 and at 116 end of October 2016. I am pretty certain that the first 35 Mauritian patients are behind this big jump of 64 in these 6 weeks. So I have no issues with the dates the blogger/patient mentions 3) I fully agree with your point 2 (placebo effect) What are you saying: that because there hasn't been any dosing between December and June the effect should have waned ? Maybe, maybe not. First, do we know if these people are in not the OLE ? But more importantly, a TRULY DISEASE MODIFYING DRUG, WHICH I KNOW LUPUZOR IS, SHOWS EFFICACY EVEN AFTER THE TREATMENT STOPS (not ad aeternam of course, you know what I mean I'm sure).
BLISS are outdated trial designs, successful thanks to powering as you correctly point to. Their innovative component was the introduction of SRI as a composite endpoint (i won’t elaborate here, but quite significant), which has been since the endpoint of choice for all late stage trials in SLE. What BLISS didn’t incorporate was the strict control of background therapy in order to minimise the placebo response (which shouldn’t be refered to as placebo but more accurately as control). This critical feature must be attributed to AstraZeneca/Medimlune in their ani trials. IMM must have been aware of it but they decided to ignore it. Fatal mistake. Let me correct, not a mistake: bad judgment or lunatic bet.
Mauritius is 70% Indians, 25% African. The ethnic diversity is not the reason for having 1/4 of the trial done there. If anything only the 25% black patients are really relevant as these are particularly affected as we know from US epidemiological data. The only reason a center was set up in Mauritius is due to the local prime minister having a personal interest in the disease/science/product. She approached ImmuPharma with 35 patients ready to go, literally. How they performed (49 in the end not 35) is still unknown, although it is fair to say that their impact must have been less than what I feared originally. As I referred to in a previous post, historical data shows clearly that centers in developing countries have much higher placebo responses than western centers in lupus trials.