WOW...Excellent post Sokol! Very informative.
I no longer have any doubts that the SAS program will lead to full approval by the TGAin Australia. And, based on this information, I believe Anavex will use the same strategy to get full approval throughout Europe.
"Early Adopters" or brand advocates can be identified as a wider group of physicians gain experience with the drug, and physician loyalty may be developed. Furthermore, key opinion leaders often play a major role in discussions with regulatory agencies.
Equally with respect to patients, as well as providing them with access to a potentially life saving medicine, there is the opportunity for feedback, the development of patient loyalty and building relationship with patient advocacy groups and associations.
There is the potential for early revenues in countries where EAPs can be designed as "for-profit" programs, but whether or not a drug is made available free of charge, market penetration can be maximized pre-launch through an EAP, which can then translate to a successful launch and increased post-approval usage. In practice, a good rule of thumb is that first-year market penetration after employing an EAP strategy is equivalent to the second year market penetration of a regular launch. "
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