Patient granted 2/23/21 to FGEN for enhanced erythropoiesis and iron metablolism.
j
Pamrevlumab sees a competitive drug shipwrecked. Galapagos shutters P3 in IPF. A little icing on the Roxa cake.
W
FDA approval in March
S
Wondering why no one is showing interest. Great opportunity.
Y
FibroGen is up 6.01% to 47.30
S
I believe the situation is now in favor of AKBA now. Requesting additional data might mean FDA did not receive enough data in the first place or they are not satisfied with the scope or the quantity. Who knows they might require FGEN to conduct more trials. This 3 month extension could turn into a rejection or further extension or a request for more trials. When i previously compared FGEN to AKBA everything looked in favor of FGEN timing and the data but now it is a toss up. But it is also highly likely that FGEN will satisfy the requirement and drug is approved in 2021. Market doesn't like uncertainty and this is why the stock was down in after hours trading and AKBA was slightly up on the news.
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Requesting additional data is very normal. Typically, the company has the data and just need to present it in a way to satisfy the FDA questions. After all, this drug is already commercial in China. You can call the data that would come out of China Phase 4 "post-approval" data. There have not been any surprises from China post-approval and the FDA knows this. They are simply requesting additional data to support approval once granted. I expect that FGEN likely provided this data or will provide it ASAP with FDA approval to come prior to date announced.
Akba is going to submit for NDA during this month.
Guess what AKBA will be approved.
First mover advantage for FGEN is diminished.
Gl!
Gl!
Gl!
in the speculative version, falling down, I close the deal.