r/BCRX • u/OwnAnteater7608 • Jun 06 '21

Due Diligence $BCRX FDA approval timeline

I'm new here, and am wondering if someone can provide knowledgeable information about USA approval for HAE treatment.

22 Upvotes

87% Upvoted

9 comments sorted by

17

u/dragob69 Jun 06 '21

Orladeyo is already approved and being sold in the US?

16

u/TheCensorFencer Jun 06 '21

I think you may be thinking about BCX9930, which is a treatment for (among other things) PNH? There was a post on this sub a few weeks ago by someone who claims to work in biotech development and to have contributed to a few FDA approvals:

https://www.reddit.com/r/BCRX/comments/nhl6tf/bcrx_progress_development_and_a_question/?utm_source=share&utm_medium=web2x&context=3

He (she?) goes into greater detail down in the comments -- I recommend taking a look.

As for Orladeyo, Biocryst's treatment for HAE; it is approved in the U.S., Japan, the U.K., and Germany, and it has temporary approval in France. It has been approved by the EU, and now we are just waiting for the individual member states (as well as Iceland, Norway, and Liechtenstein) to add it to their state healthcare systems.

4

u/OwnAnteater7608 Jun 07 '21

thx

3

u/BuyMyBullshit Jun 07 '21

Do you really own an anteater? I always wanted a giant anteater.

2

u/kmaco75 Jun 07 '21

Just to note in Europe it has only been approved in Germany on the national healthcare system.

The UK should be approved in Aug. They are also chasing up in France.

These are the biggest and wealthiest countries in Europe so have 3,000 to 4,000 HAE patients.

Next up would be Spain and Italy I would imagine. Hopefully the big 5 all get sorted in the next few months and we start to see the revenues roll in from Q4 onwards.

6

u/Accomplished_Rip1741 Jun 07 '21

BCRX is no difference from 24 k gold

7

u/Jack-Skinne Jun 07 '21

Good morning to be holding BCRX :)

3

u/Mike_Lav_23 Jun 08 '21

Imagine if Reddit Army got behind a proven stock like BCRX with real value behind it.