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05/08/23
23:58
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Originally posted by GoblinSlayer:
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To all.... While everyone is in shock and overwhelmed by the implications of what has happened here, I am not surprised that some of us are finding it SO DAMN EASY to lash out at the top man - both blame and shame - if only to make themselves feel a little bit better. Despite that, honestly, some of us long-termers might actually need a little of that right now. It's also where the goblins come in saying "I told you so" while the responsible, ethical and intelligent ones cower in fear and horror that the shorters and parasites may have actually been right. So maybe this IS the time to really unpack everything that has happened over the last 3/4 years with MSB/MESO and figure out if Silviu really should be forced to walk the plank or offered commiseration cuddles. What brought me to reason from the deep, dark realms of rage was Gavint's comment "He did say that MSB had planned to do these adult trials anyway, but why aren't they already complete or underway, without the FDA needing to tell you your job." Coz dammit, he's right. A good business man ALWAYS has a backup plan. I do. I don't have all my eggs in one basket. As above, if we were planning on adult testing, why don't we already have the foundations up for that in progress RIGHT NOW. And why has everything else, including heart and back pain seemingly ground to a halt? Why do we also not have a MASSIVE footprint in Japan having products for MULTIPLE issues that are so close to end-point that the Tokyo rock boys just might pick them up? I'll cut this comment short and stop before it becomes a proper rant - but seriously - it's time to ask the question. Is Dr Itescu really the right man for the job or not? Whether the FDA or Itescu is to blame for this single-point failure is NOT the question. And, as some of us are going need a while to figure out how to react, probably the best way to give an answer is to offer a personal percentage for and against. I am currently 30% for Dr Silviu Itescu to stay and 70% against. For the future of OUR company as shareholders (part owners), what say you? GS
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Originally posted by Bigdaddio:
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I reluctantly concur. I cannot understand his logic on the CC today - intimating they knew that a trial in adults would always be required. FFS! He said after the last CRL they had an adult trial protocol ready to go (offered that at ODAC as well) and he expected to have that CRL sorted out in 6 months ! Muppet! FOS! Bottom line is that no approval will be granted for remestemcel until it gets administer in another trial with appropriate results from that trial. As for an AA for children following a type A meeting - how could anybody be foolish enough to suggest that given the BLA for children has just been tossed.
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It is very easy to throw stones in this circumstance, but to really throw a stone, you need to look at all the facts and then see where the alternative path was going to take you. Some are saying that the company should have launched every trial under the sun 2 years ago. We know FDA agreement for CLBP, and the following trial design has only just completed late last year, into this year. So they could have started maybe 3 months ago, and be down to 50 mill in the bank. We also know the FDA would not let Mesoblast initiate another trial until the potency assay was agreed with them, and it's only just been agreed by FDA? So had we started an adult trial 2 years ago with the unacceptable potency assay, all that would have happened is a cash burning exercise. What are the alternatives, and how do you expect they would have been funded.