any idea, when the next CHM meeting is in February?

The information below is from Yahoo's company profile. Do you know who the founder of the company is and what their role is? I’ve never really paid attention to that.

Do you know when the company submitted for approval, and how long it took to receive it?

Did you buy back when the price hit its low today?

Scotty, did you actually invest in it? until approval it'll hinge around the same price, fluctuating just 1 or 2 cents up or down. Why do you post like this at the end of every day?

Thanks Captain!

who are you?

I’ll celebrate the success, but I can’t accept the failure—I simply can’t afford to lose that much.
What’s your take on the delay?

I haven’t lost any friendships, but I often scold myself for introducing it to others. It’s like asking your friends to invest in your own business that you believe has potential, but isn’t showing any progress. I’m really struggling with this internally.

I suggested this to a few friends back in 2020-2021 when it was around $1.60-$1.70. Later on, I stopped talking to them about stocks because they would always bring up the topic, and sometimes I’d avoid answering their calls, claiming to be busy. Even six months ago, when the stock was around 40 cents, I didn’t expect the dilution to be this significant, which would cause the price to drop below 30 cents.

Marty, whether it’s approval or rejection, it shouldn’t take this long (720 days). The process is now out of the company’s hands, the company can only respond to queries and inspection-related issues. At this point, it entirely depends on how the MHRA is prioritizing the approval process.

If the inspections rumor/leak is true, then yes, I’d expect it any day now. Otherwise, how can we know the status of the approval process? We don’t have any updates since it was submitted for approval, which we learned about through the press release. Since then, there’s been complete silence for over a year and two months.
The first encouraging leak/rumor came from the CHM meeting that took place in June 2024. After that, people here assumed the second CHM meeting would happen in December, followed by January, with news expected a few weeks after. However, those leaks haven’t been very convincing. The most reliable second leak/rumor so far is that inspections were concluded about two weeks ago, which is a crucial step in the approval process. Yes, IMO, it's any day now based on the last week's rumor.

They are sharing the news through 10-Q filings, but many investors don't check these unless the information is officially released through a proper press release.

Great news! Please check out the updates from a brain cancer patient.

https://www.gofundme.com/f/bos-brain-cancer-journey

Here’s my educated guess based on the January-end inspections—just my two cents, like everyone else is speculating.😃

There are three potential scenarios:

1. The second CHM could have taken place in January, but they might be waiting to hear from the team about whether everything is clear from the inspections. In this case, the approval decision could come any day starting next week.

2. After the recent inspection, they could quickly make a decision since everything else has been thoroughly checked over the past year. In this case, the approval decision could come any day starting next week.

3. If the company follows the standard process of holding a second CHM meeting, it could likely be at the end of this month. In this case, approval could come in the first or second week of next month.

Thank you so much, DD! Your comments have been incredibly helpful over the past couple of days during these tough, frustrating times. I might not have believed it if it came from some others, but you truly made my Friday brighter as we head into Surebowl weekend. I'm so happy!

"Hope is the essence of life - without hope, there is no life."

DD, just one last question—won't bother you anymore after this. Have you heard about the inspection delays from someone else, or is it purely a guess based on your intuition, interpreting others' comments, and the company's quarterly reports? thanks in advance 😊

thanks Dennis! happy Friday!

DD, are you 100% certain that the inspections were concluded by the end of January, specifically on or after the 27th?

So, this week's positive news - Dennisdave's messages are giving us hope for the weekend and the rest of the month. Thank you!

My Schwab account shows a 0.0019 gain in green, but does that really matter with such a small difference? We're looking forward to a big day ahead!

I assume we need to wait until the next 10-Q to hear from the company, which may provide a clue on whether they are still collaborating with the MHRA and offer insights into what's happening. After that, we can discuss the items listed in the 10-Q in more detail for the rest of the month.

When LP mentioned it, she likely believed we would have the approval in hand before the end of 2024, allowing them to start DCVAX Direct. However, they are still busy collaborating with the MHRA, and once approval is granted, they will make an announcement.

We have three Wednesdays left this month.

DrHigh, as the saying goes, "one step at a time." Let’s focus on overcoming this hurdle first, getting approval from MHRA itself has been a significant challenge for the company. It’s been nearly 14 months since submission, and DCVAX has gained notable attention through compassionate care. If there's another 5-6 month delay, we could face an additional 100 million in stock dilution. Approval brings reasonable attention in the media and the biotech world, and if the stock doubles upon approval, the dilution rate would decrease. Some people focus too much on the big picture and treat approval like an easy task, but the real challenge the company has faced over the last 15 years may be a lack of trust from business partners as the DCVAX process is complex and still lacks approval in hand.

I agree Captain, based on MUEE88's email from MHRA, it looks like the company has been going back and forth on multiple queries while maintaining silence. In my view, the only real positive update over the past year has been the news from the first CHM meeting in June 2024. MHRA's approval is the crucial step, and once that's secured, there's no need to stress about what happens next. For now, getting that approval is the company's top priority, and that's what matters most.
APPROVAL APPROVAL APPROVAL ...

Mike, check the link below from the MHRA website from yesterday. The statement below is a bit concerning, and it might explain why the approval process is taking longer.

https://www.gov.uk/government/news/mhra-asks-for-views-on-proposed-guidance-to-support-the-safe-regulation-of-new-personalised-cancer-therapies

"Julian Beach, MHRA Executive Director of Healthcare Quality and Access said:
“Individualised cancer immunotherapies, while still being tested in clinical trials, are a very exciting development in our hunt to find new and better ways to treat cancer, which is a leading cause of death worldwide.Because these treatments are tailored to an individual’s tumour, they pose unique scientific questions on how they should be regulated.”

"Julian Beach, MHRA Executive Director of Healthcare Quality and Access said:
“Individualised cancer immunotherapies, while still being tested in clinical trials, are a very exciting development in our hunt to find new and better ways to treat cancer, which is a leading cause of death worldwide.

“Because these treatments are tailored to an individual’s tumour, they pose unique scientific questions on how they should be regulated.”

https://www.gov.uk/government/news/mhra-asks-for-views-on-proposed-guidance-to-support-the-safe-regulation-of-new-personalised-cancer-therapies

muee88, could you please share the link?

thank you DrHigh!

Thanks Doc. I really appreciate your response.

The delay is unbearable and frustrating. It feels like MHRA is even worse than NWBO when it comes to delays. I just can't stand the waiting, whether it's approval or not. Please keep us updated.

Loaning out my stocks is something I've never done before. Can you explain what the potential downsides are?

I know you probably can’t share your source, but any hint or clue would be appreciated!

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
check this link ..

Aren’t they providing regular updates on this page? I noticed a couple of approvals on January 17th and 24th.
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

IMHO, the MHRA approval is the top priority, It will mean so much to the company and the team, especially after all the struggles they’ve endured over the years. Trust me, it would be a game-changer. The first thing we need is that APPROVAL.