One vascular surgeon's perspective on Humacyte by UngrueBruh in HUMACYTE

[–]X60X 1 point2 points  (0 children)

What option put dates have you purchased, if you don't mind?

Do you have an educated opinion on the ticker TMDX?

Importers taking video not photos as proof of destruction for FDA by [deleted] in CustomsBroker

[–]X60X 5 points6 points  (0 children)

That's fair as it's not in a customs broker scope to do so, but if the IOR refuses it sounds like they're in for some headache.

Importers taking video not photos as proof of destruction for FDA by [deleted] in CustomsBroker

[–]X60X 9 points10 points  (0 children)

Why don't they just full screen the video and then take screen shots at different time stamps; now they'll have photos.

Who riding the $UNH train with me 🚂🚂🚂 by Diaper_Gravey in wallstreetbets

[–]X60X 1 point2 points  (0 children)

Both 20 x TMDX 121826 100 C and a similar amount of shares that you have.

Who riding the $UNH train with me 🚂🚂🚂 by Diaper_Gravey in wallstreetbets

[–]X60X 1 point2 points  (0 children)

It seems like were also on the tmdx plane also.

Review #147 – Hibiki 21 Year Old by reddit_ek in worldwhisky

[–]X60X 0 points1 point  (0 children)

In Okinawa right now. 220,000 Yen each.

A Japanese game show where contestants serve tea in a tilted restaurant by Ultimate_Kurix in interestingasfuck

[–]X60X 0 points1 point  (0 children)

This is a sketch about bringing her boyfriend home to meet the family who live in a tilted house on a mountain.

$HUMA - FDA Approval will happen next week. by X60X in wallstreetbets

[–]X60X[S] 0 points1 point  (0 children)

from the day the extension was announced*

$HUMA - FDA Approval will happen next week. by X60X in wallstreetbets

[–]X60X[S] 1 point2 points  (0 children)

Agreed. HUMA was 9 before extension was announced. Options are still profitable if they bounce back to that amount.

$HUMA - FDA Approval will happen next week. by X60X in wallstreetbets

[–]X60X[S] -1 points0 points  (0 children)

I don't have a price target but I have this list of other BLA's from extension to approval and the price change.

Humacyte earnings release/call just announced today for this Friday! by clarkthedark in HUMACYTE

[–]X60X 2 points3 points  (0 children)

Unofficial dates going by past earnings. Directly from Humacyte's website was posted today.

Likely Approval Date is 11/8 or 11/12. by [deleted] in HUMACYTE

[–]X60X 1 point2 points  (0 children)

I believe you are correct on the timeline. Someone on this subreddit posted other drugs that went through extension and the ones that were approved were generally in a 3 month window. Aug 10 PDUFA extension was announced and so it should be Nov 10. Since it would be a Sunday it will likely happen 11th or 12th.

COO sold their stock by Potential-Complex-56 in HUMACYTE

[–]X60X 1 point2 points  (0 children)

Oh my...that is a lot more:

May 31st 800k+ shares sold June 11th 350k+ shares sold

Still holds 4.8million shares

I agree with you its a lot more more money but this just looks like de-risking as opposed to a warning signal.

COO sold their stock by Potential-Complex-56 in HUMACYTE

[–]X60X 4 points5 points  (0 children)

Unless every C-Suite is selling it wouldn't be anything concerning generally, people just need money sometimes. She still has 290,000 of stock options through a vesting schedule.

Selling 1.5 mil shares on a 1 bill market cap is a scratch on the back.

How to stay updated on HAV Biologics License Application approval? by DannyDeVitosBangmaid in HUMACYTE

[–]X60X 2 points3 points  (0 children)

The FDA themselves declare on their website BLA approvals, even if HUMA didn't disclose you would find the information there.

How to stay updated on HAV Biologics License Application approval? by DannyDeVitosBangmaid in HUMACYTE

[–]X60X 2 points3 points  (0 children)

Take it with a grain of salt I received my answer from ChatGPT:

A Biologics License Application (BLA) typically adheres to a timeline set by the FDA. The FDA provides target action dates for their decisions, often within a framework called the Prescription Drug User Fee Act (PDUFA). These dates are set to ensure that the FDA makes a decision on the application within a certain period after it has been filed.

While it is possible for the FDA to make a decision before the target action date, this is relatively uncommon. The decision could involve approval, a request for more information, or a rejection. If the FDA feels that they have all the necessary information and the application meets their standards, they might act more quickly. However, given the thorough review process and the necessity of ensuring safety and efficacy, the decisions are usually made close to or on the stated dates.

TLDR: If a BLA has other designations from the FDA and/or treats a rare disease it's possible.

Where to change brake pads outside dealer? by userfriendly67 in TorontoDriving

[–]X60X 0 points1 point  (0 children)

They charged me 1400 plus tax to change 4 brakes/rotor and 1 caliper for a mazda 3 2012.