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Saturday, March 21, 2015 10:18:54 AM
I have been giving something that was eluded to in the recent shareholders' conference call considerable thought regarding the timeline to market for MyoCell.
If the target date is for a 2019 launch, then the BLA would need to be filed by, at a minimum, 2018 (providing at least a year for processing and reply to Bioheart of filing status). That would mandate the Marvel trial be fully enrolled and completed by 2017, giving opportunity for 6 month data required for the primary safety and efficacy endpoints, as well as an additional 6 months for 1 year markers. For this to take place during the proposed timeline, Marvel enrollment would have to re-commence in 2016...which means, referring to your post, the financing must be in place this year. I believe all of what is needed monetarily has been carefully thought out prior to making comments public regarding dates for market approval ...with the past level of scrutiny Bioheart has been receiving, what would the benefit be otherwise to invite negative perception. Your thoughts?
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