Sorry for the delayed response. Most has been cov
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Posted On: 10/07/2019 2:02:43 PM
Sorry for the delayed response. Most has been covered by Trding and Zuess, but thought I would add a little more.
During the last CC NP discussed this pretty thoroughly between the CC and Q&A (trding outlined the timestamps). He said we currently have $62M and just ordered another $35M, so total of $97M commercial grade product.
Samsung will deliver clinical grade mid-2020 and commercial grade early 2021. I believe the difference between clinical and commercial grade is self explanatory, but not sure why we would need additional clinical grade from Samsung unless this is a requirement since this will be their first production (maybe that is something NP wasn't aware of until recently [FDA meeting last month??] either as this was the first time he stated such and all previous Samsung statements were very misleading IMO)? Someone asked if commercial grade product would limit our revenues in 2020 and NP stated that they could pay for an additional suite to get additional commercial grade product sooner (didn't specify, but I understood this was from Samsung......could be wrong if required to produce XX batches of clinical grade product before able to manufacture commercial grade product).
All values discussed are based on $120,000/patient/year. If sold at $35,000 the $97M is only ~$28M revenues. My take is they will need more and CYDY already knows this. Whether they place additional orders through their current manufacturer or through Samsung is unknown. My guess is they prefer to go with Samsung as they will be out primary supplier in the future but depending on demand requirements and technology transfer, may require some from current supplier initially. As we are accustomed to, money will be the limiting factor for when they purchase the additional product. IMO this will be addressed 1H2020 after BLA is submitted and pending FDA approval and when I expect milestone payments to be enough to allow us to press the gas with inventory and other indications.
Anyone know the batch processing time for leronlimab? Quick research showed 7-14 days for mABs, but not sure if leronlimab is similar and what batch size?
During the last CC NP discussed this pretty thoroughly between the CC and Q&A (trding outlined the timestamps). He said we currently have $62M and just ordered another $35M, so total of $97M commercial grade product.
Samsung will deliver clinical grade mid-2020 and commercial grade early 2021. I believe the difference between clinical and commercial grade is self explanatory, but not sure why we would need additional clinical grade from Samsung unless this is a requirement since this will be their first production (maybe that is something NP wasn't aware of until recently [FDA meeting last month??] either as this was the first time he stated such and all previous Samsung statements were very misleading IMO)? Someone asked if commercial grade product would limit our revenues in 2020 and NP stated that they could pay for an additional suite to get additional commercial grade product sooner (didn't specify, but I understood this was from Samsung......could be wrong if required to produce XX batches of clinical grade product before able to manufacture commercial grade product).
All values discussed are based on $120,000/patient/year. If sold at $35,000 the $97M is only ~$28M revenues. My take is they will need more and CYDY already knows this. Whether they place additional orders through their current manufacturer or through Samsung is unknown. My guess is they prefer to go with Samsung as they will be out primary supplier in the future but depending on demand requirements and technology transfer, may require some from current supplier initially. As we are accustomed to, money will be the limiting factor for when they purchase the additional product. IMO this will be addressed 1H2020 after BLA is submitted and pending FDA approval and when I expect milestone payments to be enough to allow us to press the gas with inventory and other indications.
Anyone know the batch processing time for leronlimab? Quick research showed 7-14 days for mABs, but not sure if leronlimab is similar and what batch size?
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