I have not had a chance to listen to the call yet but your expectation for the approval to come through by 1Q2019 is really far off. Here is a more realistic timeline:
1.) Primary endpoint for full 50 patients hits in early December assuming they recruit the final 10 patients over next 5-6 weeks (PE data will be reported later after the data is compiled). I can see this being delayed by finances. They need to raise money to pay for this.
2.) Secondary endpoint completed sometime in May 2018. Data on secondary endpoints reported in middle or end of June. Let's assume they are able to get the safety data from the mono trial by now. If not, they will need to wait until they get that. Again, getting the safety data in a timely fashion from the mono trial requires them raising the money to pay for those patients to go through the trial.
3.) At least three months for the BLA to be put together. It took TaiMed 6 months to get the BLA filed so 3 months is being pretty generous. So this takes us to September 2018.
4.) It will take at least a year for the FDA to review the BLA. So, earliest approval seems likely to be September 2019. Now, this assumes no further delays, which is not a wise assumption based on history with this drug and with drugs generally. My best guess, factoring in normal delays would be year-end 2019.
5.) This also assumes the FDA does not require a second phase III for combo. We are all assuming this will not be required but don't be surprised if the FDA does require it.
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