Replies to post #210718 on Biotech Values

[poorgradstudent]

GLPG/INCY:

I actually like what Gilead is doing beyond RA if no major safety issues this could be a really big class of drugs (assuming FDA is actually going to approve another JAK).

Definitely. The class as a whole appears broadly useful. Rheumatoid arthritis, Crohn's disease, ulcerative colitis, atopic dermatitis, lupus and psoriatic arthritis are all being tested by GLPG/GILD or INCY/LLY.

Someone on twitter posted this about an investor call with the company.

I did catch that. The relevant bit for me was:

Management noted that the issues ultimately leading to the CRL arose following the major amendment, but it was unrelated to the questions that originally prompted the additional data submission.

I guess you could say INCY/LLY were a bit unlucky, in a sense. Reading that passage, it sounds to me like an issue that may have arisen with long term treatment and became visible to the FDA with the additional data package. If so, this may be a very long delay.