Yep.... Novartis sure look like they have made a lot of mistakes recently..... Leaving the MSB deal might turn out to be yet another one on the long, long list. The only thing they seem to get right, is offering to manufacture drugs after they are fully approved by someone esle.
NOVARTIS The Phase III trial investigating canakinumab plus standard of care (SoC) did not meet its primary endpoint of a greater chance of patient survival without the need for invasive mechanical ventilation, or its key secondary endpoint of reduced COVID-19 mortality, compared with SoC1
NOVARTIS 3 weeks ago Novartis-partnered DARPin flames out in COVID-19 study, sending Molecular Partners' stock into nosedive..... That $69 million deal was for MP0420 and MP0423, two antivirals out of the biotech’s so-called DARPin tech.
NOVARTIS before then Novartis today announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint.
Novartis around the same time as above Novartis discontinues hydroxychloroquine clinical trial based on slow enrollment, remains committed to pandemic research efforts
If that is a sparklist list of decision making....... I'd say the gemstones are to be found in the discarded treatments.... they certainly are not with any of the decisions they stuck with.... I'm sure they looked " under the hood" of all those failures above.
Back on topic.
PRIOR to 31 DEC 2021 Si mentioned he hoped to inform the market by the end of this year on OTAT.... this may be because he awaits the minutes from the OTAT meeting on 30 Nov which can take up to 30 days. As said the minutes can also contain extra information from the FDA that was not discussed in the meeting but will have an impact on decisions, trials , approvals etc.
Best case here - the manufacturing potency assays are acceptable, and the CMC issues ( which were never actually divulged ) - are also acceptable by the FDA. That would be huge in itself, as it basically sets the bar for all allogenic stem cell manufacturers looking to get approval in the future. The " run another trial - this time blind placebo controlled in children " could rear it's ugly head again... and I dare say I think MSB will take the FDA to court over the unethical decision and no treatment currently available..... So would the FDA risk asking this again? Or will they agree it would be unethical, and the current trial results which showed a succesfull primary end point, and was voted almost unanomously that it worked..... has clearly demonstrated already that it does work.... Who knows, but if another trial is never mentioned again, and the FDA suggest to MSB to resubmit following the OTAT... well in my opinion that is them accepting what they asked for in the meeting probably was unethical.
By end of Jan 22 By now the CHF and CLPB meetings would have completed, and the company should know what would be required to get both indications approved and if the meetings were in Q4 then minutes should have been recieved back by then.
Sometime in 2022 Providing no curve balls in the OTAT meeting, -GvHD resubmission with 6 month re-review should occur, If the BLA is a success the company will be selling product immeditely after the BLA approval......... there is probably a wish here for the company to expand into the adult field ( as occured in Japan with the sister product ) , so there may be more than just approval, possibly approval with another adult trial also to come. -ARDS expect the phase 3B trial to commence, and complete within 6 -12 months, which would also support EUA provided this time death is the selected as the primary end point.
CHF speculation - The pessemist in me says, the results are fantastic.. It was basically run to the highest standard possible in a trial, and although the pre-selected end point was not met, the benefits of the treatment are quite eye watering, and they simply continue the " maybe we got lucky" trend that was already identified in the phase 2 trial.... this time with over 500 patients over a 5 year timeframe. Who knows what the FDA will say here, it's hard to speculate.... but probably the worst outcome possible for shareholders would be anything that causes more delays. So that would be..... please run another trial. That is what the company expected before they saw the results, but I think now that they actually achieved what they have, they are wondering if they might have done enough already. Dr Perrin certainly thinks so. I am sure MSB could come up with a protocol that did not take 5 years to achieve, and could generate a quicker data set ( like the protocol that they changed in the middle of the trial to speed it up in the first place ) - but how long......... that is anyone's guess....... Just about any other response from the FDA will be better than run another phase 3 trial..... Investors should be ready for it though... and this time you would think based on the results so far, they would likely smash a home run for sure. Remember what they achieved here...... 80% reduction in cardiac death for class 2 with high Crp 50% reduction in 3 point mace - for all patients treated. These results are unprecedented.
CLPB speculation - MSB set the bar here too high for themselves in picking the primary end point, and failed to achieve. This may have been the gameplan all along to shoot for the stars, and if they did manage to pull it off, then avoid another phase 3 required. In either case, it's gone quite on this front as the company was waiting for some kind of feedback from the FDA on both CHF and Back pain last update I saw was around the 20th November - they were still waiting for the feedback.
I dare say the priorities at this point remain GvHD resubmission COVID trial phase 3B
Secondary focus unless the FDA give MSB a golden reply CHF trial - whatever is needed
(20min delay)