Thought I'd try throw out some educated time frames on the future of the pipeline products given the recent announcements. Please feel free to modify/correct or shed some more light:
1) SrGVHD - OTAT meeting to be held this Q so December, a new BLA re submission which will take 6 months ish to be reviewed by FDA for potential approval for this product. So around July 2022 possible approval IF things go well and no hiccups
2) Covid ARDS - new phase 3 trial to supplement the information FDA has been given regarding the 222 patients already tested in the previous study. This additional study could be 30, 60, 90 days, maybe longer. Time required then for evaluating all the data and allowing the FDA to review it. Before the phase 3 trial can commence the FDA has to confirm the particulars of the trial and ensure potency assays etc are to their liking. SO total time perhaps 6-7 ish months ( this includes trial design, 3-4 months trial time, 1-2 months of evaluation of results and anything else). If the trial time goes on the 1-2 years then i guess nothing happens in 2022 regarding this
3) CHF - only info I understood is that Mesoblast is working closely with the FDA for potential regulatory pathways of approval. So anyones guess here, maybe another P3 trial - not sure if this could be months or years
4) Back - nothing really mentioned on this product
5) Respiratory ARDS - Novartis still working with mesoblast on closing conditions, not sure on time
All in all 1st half 2022 uneventful and so perhaps SP will drop further as investors get frustrated and move their money elsewhere thus lowering the SP but not due to negative or failed news, 2nd half more likely to have more meaning full announcements with possible approvals.
above is my opinion, what are the long term holders thinking.
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