MSB 5.24% $1.11 mesoblast limited

MSB 2022 - The road to commercialisation, page-4

  1. 12,373 Posts.
    lightbulb Created with Sketch. 3370
    @stockrock have you seen this? https://www.fda.gov/media/84417/download
    This explains the BLA resubmission - I'll have another read of it, but I think you may be able to digest this better than me.

    I'm assuming the Ryoncil resubmission as a Class 2 Resubmissions, due to the following qualifications:
    3. Any data other than minor assay validation.
    4. Any resubmission with large amounts of data such as data to supportprocess performance qualification

    In terms of timeframe, it looks like the standard 6 month PDUFA - but, it should be shorter without the need for ODAC.
    CBER will review and act on Class 1 and Class 2 Resubmissions for PDUFAapplications or efficacy supplements within the timeframes specified in thecurrent PDUFA goal letter as follows:
    1. Class 1 within 2 months of the receipt date.
    2. Class 2 within 6 months of the receipt date

    Anyway, after many false starts we may be on our way to commercialisation - if we get the BLA resubmission going soon biggrin.png
 
watchlist Created with Sketch. Add MSB (ASX) to my watchlist
(20min delay)
Last
$1.11
Change
0.055(5.24%)
Mkt cap ! $1.261B
Open High Low Value Volume
$1.05 $1.13 $1.04 $6.781M 6.207M

Buyers (Bids)

No. Vol. Price($)
3 43856 $1.11
 

Sellers (Offers)

Price($) Vol. No.
$1.11 66000 1
View Market Depth
Last trade - 16.10pm 05/07/2024 (20 minute delay) ?
MSB (ASX) Chart
arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.