The Light Bulb Effect.........
Yes Dr. Cruz has spoken a few times publicly about the possibility of having a Phaselll AZD-103 start after signs of efficacy are shown during an Interim Peek at Efficacy. Sure the Light Bulb Effect would surely be a tremendous thing to have AZD-103 create in the patients but reality says that the effects will be much more progressive. But you never know!
He has also talked about putting the "Fast Track Status" to good use by utilizing the flexibility that is available to the sponsors to make adjustments etc. ,in conjunction with the FDA, within the ongoing Trial without having to go through the whole process of designing and submitting a new Trial.
There is a chance that if Efficacy is shown for Symptom Modification in a Phasell that the FDA could ask for a small Phaselll (at least 1000 patient) to statistically prove the safety of the drug while the Phasell is completed , with possible adjustments or changes like expansion, to show a Disease Modification indication. There are so many variables available with Fast Track Status that speculation is fruitless but is useful in understanding the possible timelines. ........ one timeline we know about is the pressure for the FDA to come up with an Alzheimers Drug that ameliorates the dreaded disease.
GPP all