Thursday, May 16, 2024 11:25:06 AM
ATLnsider has speculated that Northwest Bio is using poly-ICLC as a maturation and activation agent in the manufacturing process of DCVax-L and therefore, thinks it will be included in the marketing application. While I believe this manufacturing method may have been studied, I believe it was with DCVax-Direct, and not DCVax-L. Northwest Bio did not use this manufacturing method for the clinical trials with DCVax-L, so I do not believe the first marketing application includes poly-ICLC as a maturation/activation agent either.
As I’ve said, other than a few potential anecdotal cases, I don’t think Northwest Bio has enough (real-world) data to seek regulatory approval with Poly-ICLC at this time. I’m not aware of ANY actual evidence that studies with a significant number of patients were performed using this combination (or manufacturing method) for compassionate use, so this seems to be complete speculation. As far as Dr. Ashkan using it for compassionate use and collecting real-world data; I’ve seen a number his presentations about DCVax, and not once was poly-ICLC mentioned. The only data that I’m aware of with poly-ICLC, is the UCLA data, which I believe Northwest Bio intends to confirm through their own clinical studies,(both DCVax-L and Direct) as soon as possible. (after the first regulatory approval and in-licensing agreements are finalized) They might even run studies to determine the optimal method of combining poly-ICLC with DCVax; as a separate adjuvant, or as a maturation/activation agent in the manufacturing process.
BTW - I’ve read some of dstock’s posts, and in my opinion, his speculation seems rather far-fetched and not based in reality. For example, I don’t believe Merck or any Big Pharma company (except NW Bio’s CDMO, Advent) is constructing a manufacturing facility to manufacture DCVax, nor did Merck and Northwest Bio secretly run the combination trial for colorectal cancer. I highly doubt that any Big Pharma companies are currently hiring positions related to Northwest Bio, nor do I think that Northwest Bio is secretly applying for approval with poly-ICLC. Everyone is free to speculate and believe whatever they wish, so I mean no disrespect, but I’m just stating my personal opinion on this because you asked.
I think the extremely slow pace of DCVax development, and lack of communication, has led many of us to speculate that certain developments have occurred or could be happening behind the scenes. This very rarely proves true, and in most cases, Northwest Bio at least mentions, or alludes to their development plans in SEC filings or press releases, and announces significant milestones when they are achieved.
Recent NWBO News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/03/2024 08:01:40 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/13/2024 08:01:24 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2024 09:06:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/08/2024 08:30:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/02/2024 02:42:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/30/2024 11:49:38 PM
- Biophma Announces Exclusive In License for Dendritic Cell Technology, Sending Shares Higher • AllPennyStocks.com • 06/17/2024 04:40:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 09:11:16 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 06/03/2024 09:22:55 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2024 08:13:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 09:04:57 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 10:04:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/02/2023 01:31:35 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/16/2023 10:11:54 PM
- Epazz, Inc. (OTC Pink: EPAZ) ZenaDrone Demonstration to Defense Departments of UAE and Saudi Arabia • InvestorsHub NewsWire • 11/15/2023 12:19:31 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:30:39 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 • InvestorsHub NewsWire • 11/09/2023 01:00:34 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 Extreme Weather Demo • InvestorsHub NewsWire • 11/07/2023 12:29:43 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM