@Mr. Gerbz
Didn't find much info on the TCDA definciency issue, but there is this:
https://seekingalpha.com/article/43...gress-and-news-good-bad-and-ugly-of-biopharma
"The notification sent by the FDA stated that the regulatory agency has found some deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. Gerrit Klaerner, Ph.D., Tricida’s Chief Executive Officer and President, said, “We continue to believe in the potential of veverimer to be disease modifying and our goal is to work with FDA to identify and resolve the issues in order to bring veverimer to patients.” The notification did not specify the deficiencies found by the FDA.
Tricida plans to engage with the FDA and find the resolution for the deficiencies. However, the company currently does not have any plans of modifying or suspending its current confirmatory postmarketing trial, VALOR-CKD. Tricida is currently not in the position to evaluate whether it will be able to address the concerns raised by the FDA or not."
Doesn't sound like a small issue, so maybe selling off a quick rebound(currently up 3.5% in extended) might be the play here.
@RU848789 how bad does the above sound to you?
Didn't find much info on the TCDA definciency issue, but there is this:
https://seekingalpha.com/article/43...gress-and-news-good-bad-and-ugly-of-biopharma
"The notification sent by the FDA stated that the regulatory agency has found some deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. Gerrit Klaerner, Ph.D., Tricida’s Chief Executive Officer and President, said, “We continue to believe in the potential of veverimer to be disease modifying and our goal is to work with FDA to identify and resolve the issues in order to bring veverimer to patients.” The notification did not specify the deficiencies found by the FDA.
Tricida plans to engage with the FDA and find the resolution for the deficiencies. However, the company currently does not have any plans of modifying or suspending its current confirmatory postmarketing trial, VALOR-CKD. Tricida is currently not in the position to evaluate whether it will be able to address the concerns raised by the FDA or not."
Doesn't sound like a small issue, so maybe selling off a quick rebound(currently up 3.5% in extended) might be the play here.
@RU848789 how bad does the above sound to you?