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jasytian

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11/09/20

12:20

Post #: 47268257
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Originally posted by taylorstjames: ↑

Some crucial takeaways.

1) Still much looking forward to the FDA approval. Beyond GHVD they are looking at other indications!

2a) On GVHD - Hospitals can have Rem-L STOCKED day after approval. Looking at ~15 hospitals (as they do 50% of BMT)

2b) On reimbursements from insurance companies - starts DAY AFTER APPROVAL

SI - "We already have inventory, product is already made, and I don't see any reason why this product won't be used ASAP on FDA Approval"

3a) On C-19 ARDS trial interim results - Again, reiterated the case that the MOA of C-19 ARDS is very similar to MOA of GVHD. Just look at the compassionate use results in Mt Sinai!

Hopeful that label extension would be granted

3b) On the 30/45/60 interim results - "You're right that the interim analysis was just performed in the first 90 patients and we flew through that. The DSMB recommended that we continue with the trial..."

3c) On early stoppage - "We are focusing on completion of the trial and being in a position to present all the data to the FDA and have a potential label extension for Ryoncil "

3d) On Australia - Ethics approval = several hospitals in Melbourne and Sydney that will take part in the trial

4) On CHF & CLBP - "Both of these indications are really blockbuster unmet needs"

Again reiterated that its the same MOA of inflammation.

Mechanism is the same, different product, different delivery. Both readouts will happen 4th Quarter this year.

CHF - partnered with Tasly (in China), in USA anticipating to partner with a major heart failure company
CLBP - partnered with 'No.1 pain company' Grunenthal, waiting for EU P3 trial, USA also anticipating a partnership

5) On scaling up and COGS and QC -
a) Mentions Lonza, also acknowledges the much larger volume needed. Plans are already in place to increase production to meet need for C-19.
b) Mentions proprietary media using recombinant growth factors to increase yield by 5x-10x.
c) Mentions 3D-bioreactors increasing production and reduces the manual (labor) nature of the manufacturing

= reduced costs, increased volume production

6) On capacity to ramp up - they've been very judicious in terms of pre-launch capex (big pharma usually 18mths pre-approval), only invested 6mths in advance.

a) Mentions that - sales force is ready and 12mths worth of inventory is ready for launch

7) Capital - happy with capital position

8) On strategic partnership - Expects increase in royalties and also increase in revenue from strat partnerships

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thanks for your work.

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thanks for your work.

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thanks for your work.

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