THERF - ibalizumab delay

Thera (and their partners TaiMed who are responsible for drug development and manufacturing) announced the FDA decision to extend the PDUFA date from Jan. 3 to April 3.…

On October 25, 2017, at the FDA’s request, TaiMed submitted additional documentation related to the manufacturing section of the BLA, and the FDA subsequently decided it constituted a major amendment that required an extension to the target action date, to provide time for a full review of the submission. The FDA did not request any additional information from TaiMed in this notice.

The stock is down 17% on high volume as I type. It’s not the dreaded CRL, but it raises doubts and increases the investment risk.

On the bright side 2 of the analysts that cover the company, CIBC and Canaccord, are maintaining their prices targets. CIBC said “While this does come as somewhat of a surprise, we remain optimistic that Ibalizumab will be approved by the FDA, and that there is a real unmet medical need for the drug.”

For now I’m holding my shares rather than taking a profit, but I’ll be monitoring closely.

A poster on another bulletin board put it well: So, this stinks. To have Lucy pull the football out just before Linus kicks it (for you oldsters who are familiar with the Peanuts comic strip) is very irritating.

FYI, it was Charley Brown rather than Linus, and since it was absolutely predictable it seems like a poor analogy since nothing about this is absolutely predictable.

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Charlie von Braun, NOT Charley Brown
Linux, NOT Linus
Lucille Ball, NOT Lucy
Beelzebubumab, NOT Ibalizumab

But what I want to know is why all recent drugs seem to have the same name, ending with “-umab.”

{Sorry, I’m in a weird mood. I’ll get back to attempting useful commentary soon.}

"But what I want to know is why all recent drugs seem to have the same name, ending with “-umab.”

There really is a rhyme and reason for how named.
-zumab humanized antibody[9] natalizumab, bevacizumab


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I have a strict rule. I won’t invest in anything I can’t pronounce. Ibalizumab is of the table for me.