PTX 100 is going for an expansion trial next from the completed basket study. We have been told the start of the expansion trial has been delayed due to manufacturing delays in the drug. Add to that shipping delays due to reduced airtravel to Australia and a shipping crisis. I sent an air shipment to Oz last Oct and it arrived last week. To send by sea cost is now the same, and so is the timeframe.
So things have changed a lot since the world shut down. Trying to plan and navigate a way through this is difficult, as most of the delay causes are beyond the control of a bio tech CEO.
It seems from what ShellB posted above the arrival of PTX 100 is in te near term. The expansion trial can then start.
If the expansion trial shows the same or better data, PTX can then apply to the FDA for a fast track approval. They can do that because the expansion trial is for a condition with no effective SOC, so has an unmet need. Fast track approval if given, would mean the next phase 2b trial may lead to FDA drug approval.
You mention the last CR, which happened at 5c. We are in the 20c range. Just a small 4 bag rise. How terrible (sic).
I agree OmniCar is still some time away from the money shot. But there are several other parts to the pipeline that are coming close.
Sometimes setting realistic expectations helps reduce disappointment.
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