$abvx team on the gugg fireside:
- part B will be released in the coming days, has an additional 400 + 200 (relapse) pt data which will further alleviate investor concerns re safety (all on drug no pbo)
- 2 yr rat carc data and 6 mo mouse data no signals , further evidence that there is no correlation , the only lesions (mostly rash) came up (none cancerous) at what would be the human equivalent of much much higher than 50mg exposure
- very confident no black box and don’t think warning either , cited other cases where the malignancies were similar or higher without a black box or even a warning
- part B presentation will also have an updated safety table from part A , where the malignancies will be updated to reflect the correct information
- meeting pre NDA scheduled
- looping in some seasoned FDA folk in gastro for guidance and help to get it right
There were other tidbits that can happily allow me to say that the market initial reaction got it completely wrong (mgmt also to an extent but it caught them completely off guard) but this provides a second generational opportunity with $abvx
PoS for Crohns higher , no bb or even a warning (most likely scenario just fyi) this could do $10b in peak sales.
Also I actually think the setup to buy here is better than buying at $8 (knowing the blinded blended data) because we KNOW all things considered is the best oral in UC and the magnitude of effect means that it’s very likely it will be more than fine in CD as well.
To conclude my review of all evidence drives to only one conclusion Obe does not cause cancer or accelerate it. Today’s price action reflective of the narrative correcting and this only the beginning of the stock recovering to levels reflective of the unbelievable asset they own.
My next biotech short is $CAPR. @anthonystaj and I wrote a 46-page report on the issues facing Capricor. In the next, few days the HOPE-3 (aka COPE-3) study will report its data. It will not work. This is the company's only asset.
My next short is $AVXL. One drug: blarcamesine. Time is running out for Cindarella: CHMP may issue its negative opinion tomorrow, but almost definitely by the Dec meeting. Shares will drop to <$1.25, as the final nails in the coffin for this ill-conceived project are hammered.
long $SPRB. my price target is $500. rare disease is my specialty. the ERT for Sanfilippo will be approved (CMC notwithstanding) and be the new standard of care.