Ike, I completely agree with you. The top priority should be regulatory approval followed closely by some form of scientific release of the data. It sounds like these are being treated as parallel paths and publication of data shouldn’t slow the reg process. TLD release to shareholders must accompany a scientific data release, but the primary focus is on sharing details with providers.
Time permitting I am suggesting that they look into activating the EAP at clinical trial sites, minimally. The effort isn’t small but would help to iron out many logistics at sites (saving and sending tissue for commercial purposes will come with institutional hurdles). This is a gesture that both the patient community and physicians appreciate despite it being limited in access to those that can afford any out of pocket costs that they pass on. It sets you up for immediate commercial access upon approval. By doing so you also create advocates for an FDA public comment session which applies significant pressure on the approval decision. Leave no stone unturned.
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