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Wednesday, May 22, 2019 2:20:51 PM
Production/Launch
-SYNEOS Health will be doing the drug launch, they have worked with 50 other BP co's and have a good resume.
Samsung - 1st batch takes 5 weeks then they can do a 15,000 Liter batch every 2 weeks. I think they said 1,000 Patient doses for 1 year on one batch
-Also congratulated Dr. Rae on convincing Samsung to not request 50MM upfront. said it is almost unheard of in BP
BLA
-Clincal BLA - June is best case July Possible
-CMC - August to December. He is going to lean on FDA to move it up so its not december
-FDA will be infomed in may of 525 dose as the planned dose
Colon - IND Filed in a weeks weeks (most likely sooner)
China - discussed in my previous post. they are well aware of IP and are taking steps combat this maybe mfg in US ship to china
Samsung Meeting - He is traveling to Korea to present to the board on a direct investment and do ceremony for signing they did a few weeks back.
MEDIA - Joked about how no one has ever heard of us and that will change soon.
Prostate Test - No Term sheet yet, but one should be coming soon.
NP's father-in-law has prostate cancer and might be be one of the first right-to-try for Leron. His Dr at OHSU was shocked this dr existed and gave him the letter for right-to-try.
MONO (I asked NP) - Start with 240 Patients to End up with 160 for study.
BANK - they are speaking with a Bank who deals with Bio Pharmas and they are pushing for them to go it alone and if they do will likely help fund the path
Up-list (I asked NP) - no plans to up-list in near-term, they needs 1.5 years worth of cash on hand. this we will get crushed if we do it too soon.
Recent CYDY News
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- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:17:30 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:16:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 09:09:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/09/2024 02:30:20 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:16:47 PM
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- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 02/22/2024 10:16:11 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/22/2024 05:15:08 AM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 02:00:24 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/12/2024 10:31:57 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/29/2024 10:22:17 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/29/2024 01:40:14 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/19/2024 10:15:35 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 01/16/2024 10:16:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:04:57 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:04:20 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:02:59 AM
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