Asking the real questions. If I was to guess I would say ODAC is not involved again as its the same thing being reviewed just with different results. Likely just straight to the FDA.
Timelines......I honestly do not know.
My mind is telling me 2nd quarter next year but again I've NFI. All I know is additional hurdles infant of us, cash burn and ODAC 9-1 yet still being rejected is in no way positive. MSB's ANN release is all "we hope, we anticipate". MSB can ask for a Type A meeting and whatever they like, doesn't mean they are going to get it.
FDA might simply say sorry but go do a proper randomised trial like we asked and we are waiting a LONG TIME for that result to come around. During which time MSB continues more capital raising and the price will steam lower.
We require incoming money. Right now all we have is outgoing and Ryoncil was supposed to be the first stream of incoming money to make us a "balanced" ship so to speak. now that has gone and I dont think people appreciate that yet and it will weigh heavily on the price when more people come to realise we are looking directly at a capital raise soon and it will be done at very unfavourable prices (unless we get a surprise ARDS etc result)
Ann: Update on BLA for Graft Versus Host Disease, page-256
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$1.46 |
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