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Message: So many questions...

"So now that you have had a day to digest and even with some details missing are you feeling overly positive, somewhat positive or no mucho?"

I am in between somewhat positive and overly positive.

I was really hoping to see the CKD renal function data yesterday. Whereas the total BETonMACE population (2425 patients) had a median baseline eGFR of 99, the cognition subgroup (469 patients) had baseline median of 70, and in the MoCA <22 group median baseline eGFR of 65. So although the cognition subgroup eGFR is not as low as the strict CKD subgroup (all <60), this would have been a very informative piece of data to know if after 1-2 years on apabetalone if the renal function in the cognition subgroup improved. Unfortunately, we may have to wait to party in New Orleans in March for this kidney function data.

I would have also loved to see the clinical chemistry changes (i.e. ALP, HDL, hsCRP, etc) for all patients in the cognition study, and also after treatment instead of just baseline. In the CTAD slides, they showed significant lowering of ALP and a strong trend (p=0.10) for elevated HDL by apabetalone in the MoCA <22 group, but no other post-treatment clinical measures and no data for the MoCA >22. Right now, all we have are clinical chemistry changes for the total 2425 patient population. Seeing as the CKD group with eGFR <60 had incredible MACE reduction, and also seeing as the cognition subgroup is enriched in patients with reduced kidney function, we can only speculate right now that the apabetalone mediated improvements in clinical chemistry measures were even more pronounced in these CKD and cognition sub-groups. Again, we might need to wait for the Big Easy in March to be enighted about this.

Both in the post-AHA webcast and the post-CTAD webcast, DM showed the slide stating:

"• Breakthrough Therapy status filings, both FDA and EMA, over the next 90-120 days

• SGLT2i partnering discussions, one has already been initiated, key patent already filed

• Renal partnering discussions ASAP

• Congestive Heart Failure partnering discussions ASAP, already initiated

• Orphan partnering discussions initially focused on PAH and HIV only at this time. PAH enrollment has already commenced. HIV funding being derived from a yet to be named US based organization

• MoCA partnering discussion in progress [only shown in the post-CTAD presentation]."

So seems very positive, but they are all discussions except for the key patent filing and the plans for Breakthrough Therapy status filings. But we still don't know the details of the patent or the breakthrough therapy. 

So until more details emerge, I am somewhere in between somewhat positive and overly positive.

BDAZ

 

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