today's video ..
Funny closing, both thank Christine at once, as good boys should do (o8>
OK, NP overstated the official 700mg result a tiny bit to be close to 90%, but let's hope that will be reached eventually.
Everything below 700mg has been confirmed as not qualifying.
Note that >= 90% is very significant, as it correlates with the proof of MOA and IC90.
New pivotal mono trial IND to be filed within this month, so a new pure 700mg study is coming up.
Interesting here is
- population size: 300 pts again?
- duration: 48 weeks again?
If they could start new pivotal 'CD04 Mono' 2H19,
fastest path assuming faster enrollment now and cash on hand:
- 3Q20 early readout after 48 weeks
- 4Q20 sBLA filing
and if things don't move as smooth and/or they wait until the CD03 conclusion to play it more safe or don't have enough cash
- 3Q21 early readout after 48 weeks
- 4Q21 sBLA filing
all pushed back one year. So that could be a realistic timeframe based on our historical performance.
TNBC kick off is also still pending.
Spelling out what nobody dares to write, the new location will also add a little bit on the cash requirements. But probably less than $1M for Florida. The costs of the acquired lab offices might also not be that high, as RP ran them on his 'non-profit' before.
+++
PS: An earlier Q what the IC90 occupancy dosage would be for cancer as compared to HIV.
In our opinion dosage for cancer must be higher than for HIV, as the cancer case will need additional occupancy of the cancer cell's CCR5 receptors. Whether this is significant higher in quantities we don't know.
But would have seen different dosage for the TNBC trial, i.e.
- 700mg
- 1050mg
- 1400mg
Most importantly using 700mg as the new floor dosage.
Earlier IV trials showed that even at this high dosage, no toxicity is to be expected.
Maybe SC is hard with these amount? I don't know.
But in such case, they could have used IV for higher amounts, as we need to proof the MOA on dosage escalation and not convenience.
