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IkeEsq

09/15/21 9:18 AM

#402189 RE: MI Dendream #402157

RE: MI Dendream:

My point, if I have one it is sometimes difficult to tell, is that prior to approval and ramping up manufacturing capabilities there are only a very small number of patients that can get DC-Vax. Maybe they can enroll in a combo trial at UCLA, maybe compassionate use, maybe some doctors have access, maybe some shady guy in a stained overcoat in an alley. But without approval it will not be available to the masses who need it. And currently manufacturing capabilities put a hard limit on the number of potential patients. That limit is dozens where soon it will be thousands.

Releasing TLD has the potential to make more people aware of DC-Vax, a published article and conference appearances can provide better information and awareness to the medical community. But those are largely irrelevant without approval, which is not really impacted by the release of TLD and a published article (although peer review could have some modest impact it is likely to precede approval by some time).

So whether TLD was released in October 2020 or is released in early 2022 (I am not suggesting this is likely) has at most a nominal impact on potential patients. However, being able to put out a clear message about DC-Vax with the data and a peer-reviewed article to back it up, has the potential to blunt fallacious attacks against the results and increase its use after approval.