After having read the study results and minutes from conference call this morning, I was firm on long-term investment with this company.
The biggest thing people fail to realize is the significance of maintaining not only bioavailable forms of iron and hemoglobin, but the fact that it is so easily administered via a safe and easy method within the dialysate with very few adverse effects is amazing.
Many critics are getting bogged down on "drop-outs" but they fail to realize that this was study mandated for patient care. These are sick people with high morbidity. These are probably people at the complete opposite ends of the bell curve. What I would like to see is why they had hemoglobin levels greater or less than the pre-determined cutoffs. These people are prone to bleeding, recurrent infections, issues with their dialysis fistulas and catheters. They are prone to excessive bleeding both internally and externally. You cannot truly fix those issues. Those people are equally distributed in both arms and so as expected, EQUALLY were transitioned into the open-arm for EPA dosing changes which may not have even fixed the underlying problem. You cannot say that if a person from the SFP arm was removed bcz of low hemoglobin that it was due to SFP failing until you follow them in the open arm and see if IV iron helps or not because they may not improve with any treatment and that then excludes SFP as a failure.
I see huge potential in SFP ten-fold over calcitriol. I was skeptical before but am 110% sold but would love to see the data explaining the removals but that worries me none.
When more data is released, I bet we will see that, with respect to control arm, far more of the anemia related drop-outs for SFP are related to Hgb getting too high, leading to ESA dose reductions.
Likewise, I suspect, with respect to the SFP arm, that far more of the anemia related drop-outs for the control arm were related to Hgb getting too low, leading to ESA dose increases and IV iron use.
These assumptions are based partially on the PRIME results, which showed a significant increase in ESA doses amongst the control arm in order to maintain Hgb levels.
Increasing ESA doses and more IV iron use adds significantly more costs to dialysis centers. PRIME study illustrated that SFP reduces ESA dosage by 37%. That is a significant cost saving for the company. Further, it would reduce the need for high dosage IV iron use. Doing the PRIME study was brilliant in terms of marketing SFP to these centers.
With the budget cuts for these dialysis centers, now more than ever do they need ways of reducing costs, and SFP will allow them to do just that.
With the Stifel PT upgrade (dilution-adjusted) from $7.7 to $11 today. I am feeling very good about my investment in this company. Keep in mind that the $11 target is BEFORE the expected PDUFA date. There are not really any de-risking events from now til the NDA/PDUFA, since CRUISE-1 p-values were significant enough to be certain of CRUISE-2 success... Thus I fully expect to see $7 long before CRUISE-2 results, which will be coming out in Sept at the latest.