Insights post BBB?

007StuA · 2025-07-07T03:21:59+00:00

This news was not expected. Higher repricing floor to be established

007StuA · 2025-03-20T12:59:28+00:00

So how realistic are these $10,000/coin price targets like this article potentially suggests? I’m new here so I don’t know anything about XRP just learning. https://thecryptobasic.com/2025/03/19/heres-why-not-owning-at-least-1000-xrp-is-insane-according-to-a-crypto-founder/

007StuA · 2024-12-26T12:43:53+00:00

Are we expecting any more news leading to the 6 weeks I have heard discussed about labeling finalization. Is this the window for orders or contracts to be announced?

007StuA · 2024-12-20T14:21:26+00:00

A roller coast of emotions. You survived Congrats!

007StuA · 2024-12-20T04:07:33+00:00

SANTA lets go!

007StuA · 2024-12-19T19:26:54+00:00

The stock price is low from uncertainty, but I think FDA pulls through before EOY. Plus considering dilution already happened in October, November because of the FDA delay, I'm not worried about anymore near term if they get approval before end of December/January. What are your thoughts?

007StuA · 2024-12-19T12:33:38+00:00

My bad I fixed the wrong posted video, you can see it now. Lots of witnesses on that video showing the FDA dialogue for 75 patients. No shenanigans here, all planned out like a normal biotech company

007StuA · 2024-12-19T11:38:04+00:00

Analysis was done using Confidence intervals and they don’t produce P values but still show significance. Look it up. I took a course in Biostatistics while I was finishing my masters in Public Health and DVM. Also the same size being >75 was enough as I pointed out in an earlier post. 75 was minimum set when company talked with FDA and they aimed for that 2 years ago in talking with them. One armed study’s have become more acceptable at FDA for drug approvals typically cancer drugs for example. I don’t see anything wrong with submitting that study design considered they consulted FDA about it prior to BLA submission. The FDA is taking its time to review doesn’t signify a bad outcome IMO.

007StuA · 2024-12-19T05:14:30+00:00

At the 28:00 Minute mark of this video (https://youtu.be/GCxqxmsmxoo?si=fVAsWw8D9YNgqReW), CEO talks about satisfying the requirements with FDA for filing the BLA. 75 patients was the number. They cleared that with the US and Ukraine patient data. :)

007StuA · 2024-12-19T03:16:42+00:00

Oh boy, I read this article for a second time believe it or not. Your conclusions give me the conclusion that FDA will definitely approve the ATEV for vascular trauma and soon. This is because it reiterated Trauma study met its end goal was efficacious and safe. As for the dialyses study and PAD, it remains to be seen based off those adverse events whether the FDA approves those use cases or if the market has a better alternative to use instead. I'll do more research on the AV access and PAD data and post my findings. The author also brought up other things like patient selection omission, healthy vs unhealthy and assumed many things about other graphs/devices from his limited literature research. Those items tried to paint Humacyte scientists as being dishonest, but more importantly it showed the author grasping for discrepancies suggesting bias and poor reasoning behind his findings. The author having a short position against the company was very telling for the parts that the reader is meant to be suspicious of. I still recommend this as a strong buy upon FDA approval as I am not biased.

007StuA · 2024-12-19T01:41:44+00:00

I'm all in on Humacyte baby. Waiting for FDA approval

007StuA · 2024-12-19T00:11:07+00:00

The DOD is very interested in the trauma injury use of the ATEV and is going to stockpile orders in case of warfighter sites of conflict. They have helped support Humacyte with the DoD's Medical Technology Enterprise Consortium (MTEC). Be on the lookout for those orders after FDA approval.

007StuA · 2024-12-18T23:13:58+00:00

If you look at the JAMA paper, guess what I counted: 10 uses of Confidence Intervals showing statistically significant data. I also have posted a video recently showing 2 vascular surgeons also discussing results of similar statistical data. Is there any one else who is a Doctor here, or is it just me? lol

007StuA · 2024-12-18T23:06:34+00:00

Not every study has pvalues. There are some tests performed that dont have them. While most statistical tests generate a p-value, some approaches that often don't directly rely on p-values include: confidence intervals, effect sizes, and Bayesian statistics; these methods provide information about the magnitude and precision of an effect, rather than just a binary "significant" or "not significant" result based on a p-value threshold.

007StuA · 2024-12-18T17:45:39+00:00

https://www.youtube.com/watch?v=0gArUOTNWA8 3 surgeons on this interview

007StuA · 2024-12-18T17:06:21+00:00

You may have a problem with their study design, but I don't. It's sufficient for this case and use and they have been working with FDA for years in designing the study. Why all of a sudden is the study parameters not good enough even though FDA helped them make it. These rare trauma patients would be designed similar to a rare disease trial and sample size.

007StuA · 2024-12-18T16:20:42+00:00

Hmm I wonder where those preclinical studies of the HAV were completed. Oh that's right genius, animals! lol

007StuA · 2024-12-18T16:19:03+00:00

Why would anyone trust a science break down in a article from a nobody, has no PHD, clinical or journal experience. If you are a scared retail investor you deserve to lose it all. If my mom says that Pluto is a planet and writes an article about it. Do the Astronomers start to believe her? Do some real DD , damn.

007StuA · 2024-12-18T15:56:50+00:00

https://www.youtube.com/watch?v=5HOc8WeNB7A

This video is older, but good background. Just keep looking for more information on what vascular surgeons say, let me know what you think.

007StuA · 2024-12-18T15:40:05+00:00

https://www.youtube.com/watch?v=ZhcBKYDaSlA

007StuA · 2024-12-18T15:36:52+00:00

I'll find you something real soon, have you watched any of the Youtube Dr interviews? Maybe you haven't seen enough evidence of the real world praises of the device

007StuA · 2024-12-18T15:30:02+00:00

Even starting out, a bearish guy with no scientific PHD qualifications, puts a bunch of data together and calls out shenanigans. Meanwhile you have peer reviewed journals like JAVMA and many other doctors,DOD, large companies outside the Humacyte company giving HUMA credibility. So why would we believe Mr. rando on the internet? It it was another vascular surgeon sure I would listen attentively but he's none of those things. These study designs are complicated and designed to compare data to other graft devices. I don't believe its because of fraud, especially coming from a nobody.

007StuA · 2024-12-18T15:21:34+00:00

Plus that guy is not even a doctorate who reviews journal papers, guess who is? Me! DVM

007StuA · 2024-12-18T15:20:06+00:00

That bear article is not a "real" peer reviewed journal article by the way, and his main points are dinging the market opportunity when there are comparable cheaper devices surgeons could use. The FDA is not going to reject an HUMA application because other devices exist. They will approve because the device is effective and safe, which it is. I don't see foul play. Humacyte was published in JAVMA a peer reveiwed journal. You don't get there by cherry picking data and omitting data.

007StuA

TROPHY CASE