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Re: None

Monday, 09/13/2021 2:50:23 PM

Monday, September 13, 2021 2:50:23 PM

Post# of 721108
So, DI is sayin:

1. Can’t say if journal articles submitted or not.

2. Can’t say if Sawston inspection conducted yet or not, but can say Covid no longer seems to be an impediment to that process’s timeline.

3. Can say that it appears they want TLD and Journal publication close together because they anticipate needing to clearly explain primary endpoints, because they are a recent innovation used by the FDA. This is essentially what Senti just said today or yesterday.

4. Aren’t worried about needing financing anytime soon, but would be easier to finance at 5.00. (Note: I’d be totally fine with that, I bet I could almost speak for everyone on that, as long as it’s not obtained by a prerelease reverse split.)

5, Last but not least, this is not about getting TLD out fast, according to DI, it is about trying to obtain approval, and a later public TLD announcement won’t slow down approval decision being made.

# 4 and # 5 are probably very encouraging, except that it also means absolutely nothing about even the vaguest idea regarding estimated TLD and publication timeline. TLD announcement does not appear to be their number one, two and three priority, but trying to obtain approval does.

JMH
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