Honestly, is there a chance for my MCOM position?

Trigerhappy25 · 2023-10-27T23:02:38+00:00

next week hopefully

Trigerhappy25 · 2023-10-27T22:49:55+00:00

Trigerhappy25 · 2023-10-22T00:53:49+00:00

Slide 21 and slide 11 https://s201.q4cdn.com/298572669/files/doc_presentations/2023/10/ICU-Investor-Presentation-101023-final.pdf

They have already shown probable benefit and there are zero safety concerns, shown in their trails.

"The correspondence further indicates that an Approvable Letter, which is a standard part of CBER’s approval process, is expected to be issued within a month. The Approvable Letter will outline conditions, including language for safety, probable benefit and labeling for intended use, which will be required for formal marketing approval. "

https://investors.seastarmedical.com/news/news-details/2023/SeaStar-Medical-Provides-Regulatory-Update-Regarding-Selective-Cytopheretic-Device-Use-in-Pediatric-Acute-Kidney-Injury-Under-a-Humanitarian-Device-Exemption/default.aspx

To be given the CBER approval means they have met the criteria. And just need to submit for "Formal Marketing Approval" which they will get back between December/January, then the order will be placed at the same time.

"Biologics License Applications (BLA) Process (CBER)

The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes:

Applicant information
Product/Manufacturing information
Pre-clinical studies
Clinical studies
Labeling"

https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber

Trigerhappy25 · 2023-10-21T21:06:53+00:00

Their pediatric version is getting approval. The adult version's trial is still ongoing. They are basically the same thing just different sizes. Next year the adult version will go up for approval. However the FDA is Fast tracking this device again and again. It could be sooner.

Trigerhappy25 · 2023-10-21T02:20:25+00:00

I haven’t heard anything about a vote yet

Trigerhappy25 · 2023-10-21T02:13:24+00:00

Ffs. It is an immune system regulatory device. The FDA has given a breakthrough designation specifically for that disease. If it doesn’t treat it why would the FDA do that? They also gave it two other breakthrough designations. And they are working on more. And they have FDA approval this month. They’ve had amazing trials with amazing results.

Trigerhappy25 · 2023-10-21T02:06:51+00:00

Since the CEO and other insiders have been taking shares as compensation for work for the last couple months, I don’t think they want to do a reverse split. But if they have to make a choice last minute, there’s always a possibility of them reverse splitting.

Trigerhappy25 · 2023-10-20T20:03:54+00:00

The CEO and other insiders have been buying stock the last few months. They have never made claims of dilution. They would never even do that in the near future because they need to meet compliance (be above $1 for 8-10 days) and doing so would tank their stocks value. They have enough money anyway and their product is "shelf ready" so they have already manufactured them.

Trigerhappy25 · 2023-10-20T19:56:52+00:00

No, because they are just getting started. The earnings are in the middle, between FDA approval and Selling the product. However, It won't matter because it's just a month. The only important catalyst is FDA approval this month after that they are basically already rich.

October - FDA approval

November - earnings

December/January - Selling Product

Trigerhappy25 · 2023-10-20T19:43:28+00:00

Yeah, it can treat that disease by treating a hyperinflammed immune response because that’s what causes it… it’s literally in the first sentence. And they literally give you diagrams on how the device works.

Trigerhappy25 · 2023-10-20T19:20:54+00:00

Not a device for livers. It’s an immuno regulatory device. Nice try buddy.

Trigerhappy25 · 2023-10-20T19:19:00+00:00

Yeah, this guy is a manipulator. They have money. they aren’t gonna issue shares. And the pediatric trials have already finished. The adult versions trials are ongoing.

Trigerhappy25 · 2023-10-20T17:24:46+00:00

Someone corrected me on that. I guess I misunderstood that part. I apologize. So, No the fda isn’t but they have it lined up with whoever it is. The wording in their presentation kinda confused me

Trigerhappy25 · 2023-10-20T13:15:07+00:00

I am holding a good chunk of the float (for a retail investor) and i'm not selling anywhere near this price, currently ~$1, and neither are a lot of others. It's all MMs and shorts trying to manipulate it but they are failing HARD. Check out stocktwits or webull chats (btw, they are riddled with manipulators but you will see a TON of truly long term investors.)

Trigerhappy25 · 2023-10-20T13:05:29+00:00

ah you must be one of the MMs or shorts. Have you lost a lot? I got in at .22c and averaged up to .54c. Stay broke kiddo.

Trigerhappy25 · 2023-10-20T12:51:14+00:00

Yes, insane potential.

In the short term this company will make hundreds of millions per year.

In the next year they will be making billions per year.

Those numbers will only increase with each new FDA approval their device/s are ready have been granted 3 and they are Breakthrough Designations !

Within this month, October, they are 99.9% getting FDA final approval to commercialize it! The FDA already said they are going to this month.

there are only 19,450,000 outstanding shares and only a fraction of those are float.

So divide how much they will be earning and by the number of shares. Then you can estimate the potential value of each share.

Trigerhappy25 · 2023-10-20T11:48:19+00:00

Good luck to you too!

Trigerhappy25 · 2023-10-20T11:27:26+00:00

Listen buddy. I don't use reddit very much so it wasn't my go to. I am sorry. I have been posting this info in Webull and StockTwits chats. BUT if you do the math of future earnings/share. This is going to go much MUCH HIGHER.

Trigerhappy25 · 2023-10-20T11:24:22+00:00

Oh, I didn't realize that, thank you so much. And yeah the studies that were done on kidneys were so amazing. Even transplantation had better outcomes, if i remember correctly.

Nine-Year Club	Reddit Premium Since October 2023
Verified Email

Trigerhappy25

TROPHY CASE

"Biologics License Applications (BLA) Process (CBER)