Wednesday, April 17, 2019 2:35:17 AM
AT 1:49 about Combo BLA
NP discloses at
- 2:05 Mono Pivotal next week, _but_
- 2:18 Combo BLA needs 100pts safety data from Mono first!
The cat is out of the bag. No other pts safety data
if being used here, but new Mono trial data which hasn't
even started yet.
100 pts 24 weeks, gives us 6 month duration,
plus 1 month data analysis.
End of 2019 or Jan 2020 would be the Combo BLA completion date
if the 100pts Mono can start until 2H19.
To kick off the mono trial to harvest the 100pts safety data
for 6 month (or 24 weeks) to complete Combo BLA they need cash.
And only after the Combo BLA has been completed,
we can safely assume it will get through within 6 more month.
Hence Combo approval would then lie within 2H20,
which has been hinted as PRO 140 production take off.
+++
TNBC sBLA (supplement BLA) is based on the Combo BLA
and would have been pushed out for ~6 month into 2H19.
Priority is to complete the Combo BLA, to allow all subsequent applications.
+++
Now at 2:46 he says he hopes to submit the BLA
by the end of July - but which year?
Did he meant July 2020?
That would match the 100pts safety data, see above.
At ~6:00 he says: End of 1Q20 ...
Hence 1Q20 is Combo BLA completion deadline now.
+++
Paying all of the bills is obviously expected,
assuming the lights will be kept on.
NP @ ~4:00: Still offers and negotiations, giving the idea that no cash injection via cheap shares would be required.
That has to be seen - I personally doubt this.
At ~4:20 the AS +100M increase: NP can't touch the 50M shares on ice for convertible notes, so he likes to have 100M new shares.
He sees 100M to be the max dilution from here on, well ..
+++
Bottom line to me:
- NP's timelines are delayed heavily
- TNBC is missing in action, not even mentioned
- Continuously trying to advertise his stock w/ Video 'News' to retail
- 100M shares to be sold soon
Timeline:
- June/July 2019: Mono 100pts safety kick off
- End of 2019: Mono 100pts safety completion
- End of 2019 - 1Q20: Combo BLA completion: 100% filed
- 2H20: Probable Combo approval
...
- 2H19: TNBC kick off hopefully
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