10 hours ago
Now that the board is quieted a bit here are some of my thoughts since release of this week’s data. One of two options is going to happen as an outcome of the end of Phase 2 meeting with fda within the next few weeks when sava reports the meeting outcome. It’s important to point out that sava would have come to this fda end of phase 2 meeting proposing their positions on Phase 3 study design, endpoints, study size, stats plan, and already sharing the outcome of their interim OL results with FDA to support their Phase 3 proposals:
Option 1: The FDA will treat sava’s data as run of the mill and guide sava to a conservative standard Phase 3 study for AD which other companies have been guided to. This would be a large Phase 3 trial appropriately powered to show statistical significance in cognitive outcome measures. I consider this scenario extremely conservative and standard strategy for Phase 3 and it doesn’t take into account any of sava prior scientific robust results. Under this scenario it is still possible that FDA would award BTD, but more unlikely given that FDA is really not facilitating development of Phase 3 and increasing pace towards drug approval...which is after all the remit of BTD.
Option 2: The FDA will recognize the unprecedented results compiled by Sava in phase 2a and phase 2b, as well as the impressive safety and cognitive outcome from OL after 6 months. How could the FDA recognize Sava’s clinical accomplishments you might ask. Well they could take elements from phase 2b, i,e biomarkers to incorporate into outcome measures into phase 3 potentially allowing for statistical adaptive Phase 3 trial, while of course having cognitive measures as co-endpoints. Powering for cognition might still be a rate limiter and thus will likely still require a large study but it brings biomarkers into study as a primary outcome measure...which is desperately need for AD trials imo. And/Or as already reported by Sava the fda could suggest or be open to the “enhancement” of The current on-going OL study allowing for additional use or decisions from such a study. Or as E2W surmised they could potentially agree to viewing the OL as a second Phase 3 (or mini Phase 3) whereby they might agree to using comparable placebos from other trials, while Sava continues to execute on their other formal phase 3 trial (adaptive Phase 3 trial). I should point out any of these scenarios under option 2, would fall under the remit of a BTD regulatory relief pathway.
Either option 1 or 2 is a win for Sava and will validate Sava’s results (which maintains or significant increasing Sava’s pps given the recent bogus hit jobs by market manipulators)....However Option 2 sends Sava’s pps into the stratosphere.
As most know I have been the biggest champion for BTD since September results and I continue to bet big that Option 2 comes to fruition. If it does the sava’s pps will rocket to levels not yet seen yet. If it doesn’t then it will just take a little longer under Option 1. Oh then there big pharma lurking in the wings lol.
Option 1: The FDA will treat sava’s data as run of the mill and guide sava to a conservative standard Phase 3 study for AD which other companies have been guided to. This would be a large Phase 3 trial appropriately powered to show statistical significance in cognitive outcome measures. I consider this scenario extremely conservative and standard strategy for Phase 3 and it doesn’t take into account any of sava prior scientific robust results. Under this scenario it is still possible that FDA would award BTD, but more unlikely given that FDA is really not facilitating development of Phase 3 and increasing pace towards drug approval...which is after all the remit of BTD.
Option 2: The FDA will recognize the unprecedented results compiled by Sava in phase 2a and phase 2b, as well as the impressive safety and cognitive outcome from OL after 6 months. How could the FDA recognize Sava’s clinical accomplishments you might ask. Well they could take elements from phase 2b, i,e biomarkers to incorporate into outcome measures into phase 3 potentially allowing for statistical adaptive Phase 3 trial, while of course having cognitive measures as co-endpoints. Powering for cognition might still be a rate limiter and thus will likely still require a large study but it brings biomarkers into study as a primary outcome measure...which is desperately need for AD trials imo. And/Or as already reported by Sava the fda could suggest or be open to the “enhancement” of The current on-going OL study allowing for additional use or decisions from such a study. Or as E2W surmised they could potentially agree to viewing the OL as a second Phase 3 (or mini Phase 3) whereby they might agree to using comparable placebos from other trials, while Sava continues to execute on their other formal phase 3 trial (adaptive Phase 3 trial). I should point out any of these scenarios under option 2, would fall under the remit of a BTD regulatory relief pathway.
Either option 1 or 2 is a win for Sava and will validate Sava’s results (which maintains or significant increasing Sava’s pps given the recent bogus hit jobs by market manipulators)....However Option 2 sends Sava’s pps into the stratosphere.
As most know I have been the biggest champion for BTD since September results and I continue to bet big that Option 2 comes to fruition. If it does the sava’s pps will rocket to levels not yet seen yet. If it doesn’t then it will just take a little longer under Option 1. Oh then there big pharma lurking in the wings lol.
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