@JB1975
Shame you didn’t do your research properly….if you did you would have noticed that the issues raised regarding Lonza and BMS had a little twist….not that you were to know when finding one potentially tainted example to use against this Company.
I didn't find it really just remembered that I'd read it and found it on this message board and referred back to it.
Seemed like LED was replying to something whytee had said with a bit of miscellaneous ramping about Lonza and maybe a bit of counterpoint might bring the balance back closer to the middle.
Let me update you on the storyline with reference to your own quoted source material .
https://www.fiercepharma.com/pharma/major-blunder-ex-staffers-blast-bristol-myers-squibb-s-handling-breyanzi-approval-latest-cvr
So the six month delay at BMS allegedly saved them billions of contingent payments ? Note this was a whistle blower case with witnesses for the lawsuit coming from within the company….Okay, but why have you changed the subject? - is it your view still that the Lonza had 33 successful site visits or do you think they had 33 site visits some of which (an undisclosed number) were successful? It's kind of hard to tell if you've changed your mind or not, but I do see that you've added to you sign off comment line.
Sad that you spend so much time disparaging such a desperately needed therapy for children who have up to 90% mortality rates for severe forms of this disease.I acknowledge your right to do so, but my stomach churns at the thought of such behaviour.I disagree with this characterisation.
This is an unmet need for goodness sake.Really? Is there? How do you know for instance how much "unmet" need isn't being "met" through compassionate use - where physicians (perhaps like Dr Joanne Kurtzberg) obtain access for particular kids through approaching the company for compassionate provision of cells?
Right now, I actually forget whether there is any restriction on providing cells for free on compassionate grounds or not. I don't recall there is - but I could be mistaken.
How do you personally estimate the genuine amount of unmet need in the United States where the FDA has jurisdiction currently?
In my opinion the total lives lost may be less looking forward 10 years or so - if the FDA doesn't grant a BLA but requires MSB to get the confounding out of their data before giving them a BLA.
Might have something to do with the fact that if a seven year exclusive license is granted for this orphan indication, the claims of another listed Aussie early stage biotech reaching commerciality for its steroid refractory treatment for aGVHD will be pretty much grounded in my opinion.
I think you mean CYP. In my opinion they aren't close enough. MSB could get another CRL and still be ahead by doing another trial in adults.
I still believe there is long term value for them in large volume low price applications like for such as diabetic foot ulcers, but they are deluding themselves over aGVHD . OPIronically, I got reading about another ASX listed company, that I noticed has a trial for DFU.
Please do not rely on the accuracy of any facts or opinions (including statements made in referenced publications) when making an investment decision.So are you changing your opinion on the 33 successful site visits or just changing the subject?
Because I still don't see what you said you saw.
Let me quote you to you
"To show how certain posters are now clutching at straws, I reference the 33 successful inspections undertaken in 2021".I don't see that "33 successful inspections" reference - did you misplace it? Maybe its somewhere else?
(20min delay)