One of the greatest deceptions is exaggerating trial recruitment timelines and readout far into the future based on historical U.S. data. This is inappropriate because the trials are not in the U.S. and the likelihood of provisional approval is high simply because there are no effective treatments for these diseases
Those promoting a likelihood of early approval are doing so on the premises that: 1. 2-73 has already shown extraordinary efficacy results 2. Australia is "ahead of the curve" with their recently approved pathway to early approval
#1 is preposterous...no scientist (e.g. Hampel or others) would make that claim. #2 is just Australia playing catch up with the FDA and the EU (as they directly state in a document I posted)
Can a drug be approved early? - yes, none of these agencies tie their hands. How often does it happen? Very rarely in the face of extraordinary results in diseases that have poor treatment alternatives and in populations in which recruitment is slow/difficult. 2-73 has 1 of those 3 criteria. There is no credible reason to EXPECT early approval. To say otherwise is UNHELPFUL. A rational investor would look to "historical US data" for reasonable timeline expectations.
Those that say that any approval must wait till 2020 are giving misleading information, in my opinion.
There could be data read outs in 2020 but approval requires a data read out and they'd need a read out by mid 2019 to have an approval before 2020. That is just not going to happen, they are barely getting started on trials. PDD is furthest along and the PDD registration shows hope to be done collecting data in 12/19. IF they meet that date then they should read out in early 2020...however I'd consider that best case because when is the last time AVXL met a self-declared deadline?
Once they read out, they need to show efficacy. THEN, those efficacy results would need to be so spectacular that the FDA does not require a 2nd pivotal trial (as they do for most compounds).
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