Replies to post #146422 on Biotech Values

[jq1234]

BAX also stated in PR they need to further discuss with FDA before filing amendment:

Baxter plans to file an amendment to the BLA for HyQ following additional discussions with FDA.

Even if non-neutralizing antibody produced while injecting with mAb products like Herceptin and MabThera might not be issue at all.

Hylenex label is with very benign warning on hypersensitivity (rarely). No mention of non-neutralizing antibody at all:

http://www.hylenex.com/Theme/Hylenex/files/doc_downloads/LBL293-03.pdf

Sorry to hear you are still long a fair amount. I had been out of it for awhile, had been waiting for the CRL for possible re-entry - I was more worried about potentially FDA found camouflaged hypersensitivity reaction from clinical trial data, never thought drop like this.

[pcrutch]

I agree 100% on the suspect management for 2 reasons.

1- on BAX 2q call they said they expected a CRL soon, but no mention from HALO about this.

2- Roche said they were moving forward with MabThera etc, but again no mention of this by HALO

Not the kind of company I want to invest in. Clearly something was up and they chose to say nothing instead of act.

[turtlepower]

HALO - I'm not as familiar with HALO. Will Roche file for SC approval in the US for both Herceptin and Mabthera? Only EU applications were discussed in today's call. Thanks.