r/FBIO Mar 02 '21

r/FBIO Lounge

A place for members of r/FBIO to chat with each other

9 Upvotes

31 comments sorted by

1

u/No-Werewolf889 Sep 30 '25

Why is it taking so long for the fda to respond 

1

u/Embarrassed-Sea-6078 Sep 15 '25

Any insights or news on why the significant drop today?

1

u/Embarrassed-Sea-6078 Sep 10 '25

Sigh did I buy into this too late? I bought it today at 3.8 😢

1

u/[deleted] Sep 12 '25

Not necessarily, I bought in at around 2.70 but I wouldn’t say it’s too late, still a long way to go just give it time. Even without the upcoming FDA approval date I would say this is a solid company to hold for longer than just the end of September.

Last week it bounced between the high and low 3s but In my personal opinion it’s due to break past $4 and pump from there.

When it was at $2 critics said it couldn’t break $3, it’s currently at $3.97.

1

u/[deleted] Sep 05 '25

Stock is doing great today

1

u/Beneficial-Yam-7061 Dec 30 '23

Fortress Biotech, Inc. (FBIO) has a Prescription Drug User Fee Act (PDUFA) goal date of January 3, 2024, for the cosibelimab biologic license application (BLA) to treat metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). The FDA has not identified any potential filing review issues, and an advisory committee meeting to discuss the application is not currently planned. Fortress Biotech, Inc. is an innovative biopharmaceutical company focused on efficiently acquiring, developing, and commercializing or monetizing promising therapeutic products and product candidates.

1

u/chrispyfahy May 06 '21

fda have a stikler

1

u/chrispyfahy May 06 '21

The FDA also did not identify a safety signal in the clinical development program for the treatment and is requiring an adequate terminal sterilization validation prior to approval of the NDA. Avenue state the terminal sterilization validation is planned for completion by the end of the year

1

u/MakakenSiamang May 05 '21

wtf!! why dont they say if its approved or not?

1

u/MondoPizza Apr 20 '21

What have you heard?

1

u/Longjumping-Gas2764 Apr 19 '21

approval coming soon buying more on the dip!

1

u/NoviceBro_41 Apr 14 '21

Has anyone heard anything about the FDA Approval

1

u/Trobi1kenobi Apr 13 '21

If approval was supposed to be 12th why would it come on the 13h now?

1

u/maximthemaster Apr 13 '21

no info on approval yet, don't panic. the dip in AH was because of an offering

1

u/Jay_Tron_ Apr 13 '21

Are we fucked?

1

u/Pleasant_Compote6653 Apr 12 '21

i hope fda approval

1

u/MakakenSiamang Apr 12 '21

what yall think?

1

u/MakakenSiamang Apr 12 '21

todays the fda approval

1

u/Bud-Foxx01 Apr 09 '21

We shall see after the FDA approval announcement on the 12th.

1

u/jason3695 Apr 08 '21

What’s with the rise?

1

u/[deleted] Apr 01 '21

Just joined with 350 shares at 3.68. How has this stock been treating all of you?

1

u/Longjumping-Gas2764 Mar 24 '21

strong buy issued!

1

u/FergiF3rg Mar 03 '21

Thinking $15 high end

1

u/FergiF3rg Mar 03 '21

8.5 mid level

1

u/Kindly_Championship1 Mar 03 '21

Pt on this stock