Grey_Ghost
50 minutes ago
Today's OS is 1,276,923,405. The company has been diluting 1 million shares every business day so far in the month of September.
Lots of big lots... 20,000, 50,000, 100,000, 200,000... have been going on this past week or so with little movement in price.
beartrap12
59 minutes ago
Earlier today over 600,000 shares in two trades(283,000, 349,000?), one right after the other, about 10:30 raised the price only .002, if I remember correctly. Is that MMs somehow mysteriously holding the price down for short covering?
Lots of big lots... 20,000, 50,000, 100,000, 200,000... have been going on this past week or so with little movement in price. I know a few other posters have pointed it out.
Any thoughts?
flipper44
3 hours ago
MAA STATUS: June 29, 2024 Flashback (see quote below).
(Note: At this point, some longs are now thinking 210 window started March 7 and Goes to October 3, although everyone (longs and bears) recognizes regulatory speed is variable but improving this year. In other words, MHRA could take a little longer.
August 2 (8k) seemed to indicate inspections were planned during the last 70 day window.
On September 10, Advent received Human MIA for commercial manufacturing. This seemed to complete one of the major hurdles.)
Linda Powers, June 29, 2024
โSo, needless to say, our top priority, our laser focus, is to complete the process, and hopefully obtain our first commercial approval in the UK, hopefully, approval of the MAA.
We are well underway. We believe the MHRA is following the 150-day process that they have, but we donโt, we do not have confirmation of that. We don't have a way to be sure of that, to know it for sure, but we believe that. It, the โ150 days,โ quote, unquote, involves approximately 3 stages, and the time frame of each stage is approximate. So it's not, you know, on the button.
The first stage is approximately 80 days of initial review of the application. The second stage is approximately 60-day clock stop, when the agency is going to deliver a list of questions to us, as they do in all these processes. It's not just us. They'll deliver a list of questions. They'll ask for supplementary information, all of that. And, and we will try to respond as fast as we can, which is part of why we're trying to guess what they might might ask, and try to already kind of prepare.
The 3rd stage, which will come after the 60-day clock stop, or however long the clock stop turns out to be, to provide all the answers and info, additional information. The third stage is approximately 70 days of further review, and reaching a decision. Again, the the timelines are approximate. As as far as we've seen, there is not an equivalent thing in the UK that's similar to a PDUFA date in the US. You know, under the legislation in the US, you know, FDA can have a target date for giving you a decision.
We don't have a target date. It'll be what it'll be, okay? And those approximate time frames of those 3 stages that I described, of course, depend also on MHRA's workload, and what backlog they have, and so forth. So that's the approximate process, and the approximate timelines.
I mentioned, with a lot of emphasis, and a lot of discussion about the inspections, that they're gonna inspect everyone, and everything. Those are gonna be going on all during this MAA review process, and those will have to be completed before an MAA decision can be rendered. Right? So there's gonna be extensive inspections, and it's gonna be going on, during this period.
So we, the typical thing, we are gonna follow the typical practice of biotech and pharma companies, which is, we are not going to provide interim step blow by blow. They asked us this, we answered that. They asked us the next thing, we answer that. No, weโre not gonna do the interim steps. We're just going to tell the result when the process is finished. That's the typical approach, and that's the approach that we're gonna be taking. Okay. That's our big priority area, of course.โ โ Linda Powers
skitahoe
3 hours ago
When we speak about future valuations, if we don't include assumptions about what the estimate is based on it's practically meaningless. It's my belief that both DCVax's have the potential of treating many solid cancers, it will take many years, perhaps over a decade to verify this. If verified and approved for use worldwide, then I think discussions of trillion dollar market caps are warranted. That's the extreme high valuation.
On the other hand, approval for brain cancers only, but ultimately worldwide. That could take as many as perhaps 5 years, but at that point mid double digit billion dollar market caps should certainly be reasonable to expect.
I believe we'll be somewhere in the middle, substantial anecdotal evidence of efficacy in other cancers resulting in substantial off label use in the next 5 years. If I'm right about that, in that time we could see low triple digit billion market caps.
Regulatory approvals certainly take time, they cost money, while I believe that there is a possibility some countries may piggy back on the UK approval, nothing is certain until it occurs.
Gary
XMaster2023
4 hours ago
Learning curve, sorry I was busy this morning. Frozen tissue plays an important role in creating DCVax-L. See extract from Google search
DCVax-L and Frozen Tumors
DCVax-L is a personalized immunotherapy treatment that utilizes a patient's own immune system to fight cancer. It's particularly promising for patients with glioblastoma, a highly aggressive form of brain cancer.
Frozen tumor tissue plays a crucial role in the creation of DCVax-L. Here's how:
* Tissue Extraction: During surgery, a portion of the tumor is removed and immediately frozen.
* Cell Isolation: The frozen tissue is then thawed, and specific immune cells are isolated.
* Vaccine Creation: These cells are cultivated and engineered to recognize and attack the patient's unique tumor cells.
* Administration: The resulting vaccine is administered to the patient in a series of injections.
Key Points to Remember:
* Freezing: The tumor tissue needs to be frozen immediately to preserve its properties for vaccine production.
* Preservation: The tissue should be stored without preservatives or chemicals that might interfere with the process.
* Gliadel Wafers: If Gliadel wafers (chemotherapy-soaked wafers) were used during surgery, they can interfere with DCVax-L's effectiveness.
If you or someone you know is considering DCVax-L treatment, it's essential to discuss the specific requirements with a healthcare professional. They can determine if you're eligible and provide guidance on the process.
Would you like to know more about DCVax-L, glioblastoma, or immunotherapy in general?
Thus, for months facilities & PATIENTS from AROUND THE GLOBE have been freezing their tumors. I would bet these frozen pieces have been transported to the UK. When they change the designation to HUMAN what would stop them from fabricating the Vaccine? Understanding of course they cannot distribute until approval. Iโm sure, in some cases, they will begin the fabrication process.