Ok responses from London and Invest. London's opinion is that it will be Incyte rather than Novartis (Novartis being Incytes partner for Rux/Jakafi) undertaking the lawsuit via Lassman.
MSB Trading 2021 - paradigm shift, page-785
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The full petition with its 11 attached documents can be found here:
https://beta.regulations.gov/docket/FDA-2020-P-1689
The key document is:
https://beta.regulations.gov/document/FDA-2020-P-1689-0001
(download the pdf by pressing the Download link there).
It was submitted on July 20th 2020 by this law firm. I did not see Novartis mentioned in name, but clearly this petition intent is to claim Ryoncil data is not good enough for approval and asks the FDA to not approve it for sr-aGvHD as it is against standards and ethics, and will hurt the sales of Jakafi unfairly (in their view). This indeed clearly means they represent Novartis.....
The main claim was that the original Osiris phase 3 trial failed, which is true, although that trial did show trends and good subpopulations for which there was benefit to measure in subsequent trials (which MESO did, with the new trials for pediatric GvHD), and that the data supporting is only from a one armed trial and using a drug without a well established MoA. They asked all this petition will be given to the ODAC (this was before that...).
The ODAC as we know, spent a lot of time on these issues. The one armed trial. The failed Osiris trials and the differences in current method. The inability to have a double arm trial for kids. The very strong effect seen on that one arm trial in general and when compared to matched population not participating. The safety profile, and if I'm not wrong even the fact that Jakafi itself was approved for GvHD (for ages 12+) using a single arm trial of 50 patients only.... (how weird is claiming that on Ryoncil, while they have done LESS). The vote was 9-1 as we know.
Now... it seems the FDA final decision is exactly the slogan of this petition. They want another double arm trial. Did it affect that part? Was that what convinced the regulators do it? This petition?... This is a good question, and I don't know the answer. Certainly the ODAC gave a good answer for this. And the fact Jakafi was approved based on a single arm trial is another point... but... really I don't know.
What happens now? with Novartis in?... the damage (if it is from this petition), is already done. Is there away to take back a petition? I don't know. The damage is done in the form of already making the FDA make a decision, and turning that back is usually extremely hard no matter what caused it, because they don't like to be seen as making errors in such critical decisions.
As for the question about synergy between Jakafi and Ryoncil.... I'm not sure. You have Ryoncil, giving alone better results, with close to 0 side effects... So, medical logic would mean using it first line, try to detect responders as fast as possible, and maybe give Jakafi as a second line to the non responders (as an addition). Would need trials to measure that and how effective it is.
It's a lot of material on the links above, and I haven't gone through all of it (to say the least), but that's what I can say now about this story.
Hopefully others can maybe shed more light.
GLTA
Most likely was Jakafi themselves with no input from Novartis, or a big shorting company. Given the amount of shorts at that time and value, I wouldn't put it past the latter, but really could be either option ...