In the end, after waiting all these quarters, one more month shall not make such a difference now. The rolling BLA filing may start before they have fully completed CD02 Combo, for sure before the last 100 pts safety data arrives from CD03 Mono. Is it still just one week of 100 pts CD03 Mono data for safety?
FDA so far was very supportive and we see no reason they change that - on the contrary. They relaxed the enrollment criteria when needed, why shouldn't they allow them to fast forward the CD02 Combo with BTD? ODD was not given - too many patients, market-size too big.
So - as usual with this company, the only big question is the next financing. 1 - Buyout 2 - Partnership 3 - Value Appreciation >= $1.50 and appropriate offering 4 - Paulson Again (duck hide)
Of course, 1-3 equals to appropriate gains, while 4 would be the most hilarious situation ever around BLA filing a market-size of at least $1B drug in the US alone. $1B minimum market-size while just selling Pro140 at 29% of Trogarzo/IZ - think about that. Otherwise min $3B market size at same price.
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