0:01 Big movement today in the world of type 1 diabetes and also for pre-diabetics. The company is Seni. Their product is T-sealed. We have reported on it many times here on this channel. They are about to get FDA approval, but this is a worldwide phenomenon we're talking about because it has also been approved for treatment of diabetes in eight other major countries. [music] I have the whole story for you. Hit the like and subscribe button and we will jump right into it. >> Thanks for joining [music] us today. If you like our channel's content, feel free to hit the link in the description and buy us a coffee. We appreciate all our viewers who [music] support our channel. Now, on to our video. Type 1 diabetes breakthrough [music] sealed
0:46 approved in eight countries. FDA decision in weeks. [music] The FDA just made a decision that could change everything for newly diagnosed type 1 diabetics. And I [music] mean everything. Senofiast seal just got accepted for expedited review under the FDA commissioner's national priority [music] voucher program. What does that mean? Instead of waiting 10 to 12 months for approval, we could see this treatment available [music] in as little as 1 to 2 months. If you or someone you love was recently diagnosed with type 1 diabetes [music] you absolutely need to hear this. This is the biggest shift in type 1 [music] treatment we've seen in years. Let's break down exactly what's happening. First, [music] let me explain what just happened because this is huge. The FDA
1:34 has a [music] special program called the Commissioner's National Priority Voucher Pilot Program. This is reserved for treatments that address critical [music] public health needs, and CL just got accepted into this program for stage 3 type 1 [music] diabetes. Here's why this matters. Normally, when a drug company applies to expand a treatment's use, the FDA [music] takes 10 to 12 months to review it. But with this fasttrack designation, we're looking at [music] a 1 to2 month review process. That means if everything goes smoothly, seal [music] could be approved for stage 3 type 1 diabetes patients by late December 2025 or early January 2026. That's weeks [music] away, not months or years. Now, some of you might remember that sealed was already FDA approved
2:21 back in 2022 for delaying the onset of stage 3 [music] type 1 diabetes in at risk individuals. But this new application is different. This is about treating people who have already been diagnosed [music] with stage 3 type 1 diabetes. And that's a gamecher. And here's something that adds even more credibility to the story. [music] The United States isn't alone in recognizing Seal's potential. This is becoming [music] a global movement. The UK's MH approved sealed back in August 2025. The European Medicine's Agency [music] issued a positive opinion in November 2025 with final EU approval expected by year end. But it doesn't stop there. China approved sealed [music] in September 2025. Japan approved it in 2025. Canada, [music]
3:08 Israel, Saudi Arabia, the UAE, and Kuwait have all approved this treatment. We're talking about regulatory bodies [music] across North America, Europe, Asia, and the Middle East. All recognizing [music] that Telesamab represents a real breakthrough. Now, I know many of you watching are from India, [music] and I want to be transparent. As of right now, TLED has not been approved in India yet, but given this global [music] momentum, I would not be surprised to see Seni pursue approval with India's CDSCO [music] in the near future. If you're in India, this is something to discuss with your endocrinologist and potentially advocate for [music] with your health care system. Think about that for a second. Multiple major regulatory bodies around [music] the world are all moving on
3:54 sealed. This isn't just one country taking [music] a chance. This is global recognition that tlismab represents a real [music] breakthrough in how we treat type 1 diabetes. Let me take a step back because I know some of you might be wondering what is stage 3 type 1 [music] diabetes. Why does staging matter? The medical community now recognizes type 1 diabetes [music] in three stages. Stage one, you have two or more diabetes related auto antibodies, but your blood sugar is still normal. No symptoms [music] yet. Stage two, you still have those auto antibodies and [music] now your blood sugar is starting to rise, what doctors call dislycemia. You might notice some symptoms, [music] but you haven't been officially diagnosed yet. Stage three, this is when you get the official type 1
4:40 [music] diabetes diagnosis. Your blood sugar is high enough that you need insulin therapy. This is where most of us enter the picture. [music] When symptoms become impossible to ignore. Here's why the staging system is so important. For decades, we only treated type 1 [music] diabetes after people reached stage 3. By that point, most of your insulin producing beta cells are already destroyed. But now, we're shifting the entire treatment landscape. We're not just waiting until someone is in crisis anymore. We're talking about intervening earlier. And that's [music] where sealed comes in. So, what exactly is Sealed and how does it work? Seal's generic [music] name is Tlesmapab. It's a monoconal antibbody therapy. Basically, it's designed to modify your
5:26 immune system's [music] response. Here's what happens in type 1 diabetes. Your immune system mistakenly attacks the beta cells in your pancreas, the [music] cells that produce insulin. Sealed works by targeting specific tea [music] cells that are attacking those beta cells, essentially hitting the pause button on that autoimmune [music] attack. The original FDA approval in 2022 was based on the trial net study which showed that [music] seal could delay the progression from stage 2 to stage three by an average of about 2 years. That was groundbreaking. But this new [music] application is based on the protect trial. And this is where it gets really exciting. The protect [music] trial looked at people who were already diagnosed with stage 3 type 1 diabetes.
6:12 People who were already [music] on insulin. The results. Patients treated with sealed maintained more of their natural insulin production measured by something called ceptide levels compared to those who didn't receive the treatment. What does that mean in real terms? Better blood sugar control, [music] potentially lower insulin doses, and reduced risk of complications. Now, I want to be crystal clear here. Sealed is not a cure. You will still have type 1 diabetes. You will still need insulin. [music] But if sealed can help you preserve more of your natural insulin production, that could mean easier blood sugar management and better long-term outcomes. Okay, so here's the question everyone's asking. When can I actually get [music] this treatment?
6:58 Based on the FDA fasttrack timeline, we're looking at a decision by late December 2025 or early [music] January 2026. That's the review period. If, and this is important, [music] if the FDA approves sealed for stage 3 type 1 diabetes, then it becomes a question of access and insurance coverage. Here's what you need to know. Seal is administered as a 14-day course of daily [music] IV infusions. It's not a pill you take at home. You'll need to go [music] to an infusion center. The original approval for stage 2 patients faced some insurance [music] coverage challenges, so that's something to watch closely. But here's the positive. Because this is being fast-tracked under a national priority program, there's clearly recognition at the highest
7:44 levels of the FDA that this treatment addresses a critical need that could help with insurance [music] coverage discussions. My advice, start having conversations with your endocrinologist now. Ask them about [music] sealed. Ask about the staging system. Ask if you might be a candidate once approval comes through. Get ahead of this. Here's the bigger picture that I think is really important to understand. This FDA fasttrack decision [music] signals a massive shift in how we think about type 1 diabetes treatment. For the first time, we're not just waiting until [music] someone is in crisis. We're not just managing symptoms after diagnosis. We're talking about intervening early to preserve beta [music] cell function. This means early detection is more
8:30 important than ever. If you have a family history of type 1 diabetes, screening for those auto [music] antibodies in stage 1 could be life-changing. Catching it in stage two could mean delaying your progression to stage three. And now, even if you're already [music] in stage three, there might be treatment options to help preserve your remaining insulin production. This is the [music] future of type 1 diabetes care, and it's happening right now. Look, I'll be honest with [music] you. I'm cautiously optimistic about this. We've seen promising treatments before that didn't pan out the [music] way we hoped. But the fact that the FDA is fast-tracking this and that regulatory bodies around the world, from the [music] UK to China to Europe, are all approving this treatment, that tells
9:17 me they see real potential here. I'm going to be following the story [music] very closely. When the FDA makes their decision, whether it's approval, additional questions or anything else, I'll break it down for you immediately. And for my viewers in India, [music] and I know there are many of you, I'm watching I'm watching the Indian regulatory landscape [music] closely too. If Seni submits an application to the CDO for sealed approval in India, I will cover it immediately. [music] In the meantime, talk to your endocrinologists about Tlismab. [music] Share this information and let's build awareness. So, make sure you're subscribed and hit that notification bell so you don't miss any updates. [music] And drop a comment below. Are you excited about this? Where are you watching from? Do you [music] have
10:02 questions about Sealed or the staging system? Let's talk [music] about it. This is type 1 diabetic warriors and I'll see you in the next video. Stay strong, [music] stay informed, and never stop fighting. All right, that's tealed by Seni. We should have an FDA approval in the United States here very shortly that [music] is great for newly diagnosed diabetics. But there's also something in it for those of us who have already been diagnosed and are on insulin. So the potential there is for us to use less insulin. At the same time, we'll be warding off potential complications. This isn't a cure, but it is a major
10:48 step in the right direction. Let me know what you think [music] in the comments, and we will keep an eye on this. We'll also have another really exciting video [music] for you here in just a few days on Type 1 Diabetic Warriors. Till [music] then, have a great day. Bye-bye.
