I'm shocked and extremely disappointed to be sitting here typing with the SP at $1.09
Yeah - I could have done heaps better if I sold out and bought back in, but heck - that's being a hindsight expert!
But, given that I've decided to ride this out, all I can do is look forward to the future.
We are going to get the quarterly report this Monday (tomorrow).
Give us something SI, any possibility of a CC as well?
We definitely need something to stop this SP bleeding and start the climb upwards.
I'm hoping to hear that we have initiated the BLA resubmission and that the FDA has accepted this submission.
If so, then we are definitely on our way to commercialisation and the SP will spike accordingly.
Let's have another look at this...
Ryoncil path
A bit of Déjà vu, but this time we are going into this process with open eyes.
Assuming that OTAT agrees with Mesoblast – what is the road to commercialisation for Ryoncil?
1.BLA resubmission – given that this is a resubmission, most of the original paperwork can be leveraged with the additional data, such as potency essays to satisfy the previous CMC issues. A part from that this process should be rather straight forward and a rolling review is not required.
2.ODAC – there’s no need for ODAC as the same product has been voted previously and got a 9-1 approval recommendation. Also, it is hard to justify to the members as the FDA have overridden the previous 9-1 votes anyway
3.PDUFA – with RMAT designation, this should be within 6 months. Given that ODAC is not required, this can be reduced to 3-4 months IMO. BTW do we still have priority review on for this indication?
4.Sales team – I haven’t heard otherwise, but I’d think there are still be some sales people from the previous production readiness exercise
5.Insurance reimbursement – most of the heavy lifting has been done. This will be just the activation of some of those previously signed-off reimbursement agreements
6.Manufacturing – nothing has changed. Lonza will still be Mesoblast manufacturing partner for Ryoncil. Remember this is a niche market and we have more than enough in stock to service Ryoncil demands for several years
I’m going to have some wild guesses here:
·2-3 months for OTAT agreement on the data
·3-4 months for BLA resubmission. This can start in parallel with the OTAT discussion
·4-5 months for PDUFA
·So, all up 7-9 months, Q3 2022 for commercialisation?If we get confirmation of the BLA resubmission, then we have a chance of Q2 2022 for commercialisation.
Bring it on - we need something badly to rectify this SP bleeding!
(20min delay)