Re: beartrap12 post# 688309
Thursday, May 16, 2024 11:25:06 AM
Post#
692015
of 692109
beartrap, to market a new drug or biologic, regulations require adequate and well-controlled studies that distinguish the effect of a drug from other influences. And for regulatory approval of combination regimens, it is necessary to demonstrate the contribution effect of each monotherapy to the overall combination. This is why I believe that Northwest Bio’s first marketing application did not include other adjuvants.
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.
Re: hyperopia post# 692015
Thursday, May 16, 2024 1:26:32 PM
Post#
692054
of 692106
hyperopia, thanks again for a very thoughtful analysis of our situation. I also agree we are only going for nGBM and rGBM with NO poly ICLC in the current MAA in front of MHRA. I think it's imperative that DCVax-L be approved on its own to start. It looks like we already have a Ph I with poly-ICLC and also a clinical trial with Merck's Keytruda added, that involves poly-iclc. Details from the first trial already tells us poly-iclc is adding time to patients' lives. We're all hoping to hear more about the additio of Keytruda soon.
I also agree that poly-iclc could not have been added to our Ph III after the trial was started.
I look forward to hearing some figures from the company on how many patient have received DCVax-L + poly-iclc and how well they are doing in the real world.
It will be interesting to see if NWBO adds poly-iclc to patient treatments if and when we receive approval!
Thanks again!
hyperopia
Re: beartrap12 post# 688309
Thursday, May 16, 2024 11:25:06 AM
Post#
692015
of 692115
beartrap, to market a new drug or biologic, regulations require adequate and well-controlled studies that distinguish the effect of a drug from other influences. And for regulatory approval of combination regimens, it is necessary to demonstrate the contribution effect of each monotherapy to the overall combination. This is why I believe that Northwest Bio’s first marketing application did not include other adjuvants.
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.
attilathehunt
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attilathehunt
Re: norisknorewards post# 692005
Thursday, May 16, 2024 11:18:33 AM
Post#
692010
of 692116
It does say expired because it missed the deadline of 4/5/24...However, it looks like they resubmitted on 3/25/24 under a different number....Not sure if it matters if it is for adult or pediatric.
newman2021
Re: manibiotech post# 692017
Thursday, May 16, 2024 12:28:57 PM
Post#
692024
of 692117
hyperopia is not giving any credit to anything the 10Qs are not saying. Period. But we heard from Les the very first sentence was 'All the approvals are coming'; he also talked about the Nature publication which involves only PCLYC. So, we don't know what all goes behind the scenes. The effect of PCLYC is humongous. We don't need Keytrudas any more and so LP has changed her Cementing language to Broad Franchising. While everything is happening in front of our eyes, the shorts are covering as we speak. The share price is in a holding pattern even at these low volumes... is indicative of the shorts covering. But they don't have too much time even if we see the approval in the Fall looking at the number of shares they have to cover both legal and naked. .
