True. I misspoke in saying that there was no dose
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Posted On: 12/03/2019 11:37:43 AM
True. I misspoke in saying that there was no dose escalation in P1. But they escalated dose in P1 until they... didn't find adverse effects or declining/stabilizing efficacy? That's why I said the company should have addressed it in P2. And you're correct about it being a prior company/ownership that screwed that up originally, but it still stands that the lack of foresight is why we're still in purgatory. We dose escalated in P3, no reason we couldn't have done it in P2 to ensure that our P3 was correct from the get go.
Should the FDA have simply allowed 350mg? Absolutely. No question whatsoever. But we can't count on the FDA to be on our team, the company has to be its own advocate. And while the company has done that effectively on several occasions, it's always after the fact. NP got the FDA to agree to reduced requirements on this, or more lenient enrollment requirements for that... but always after we should have already been done with whatever it is we're getting fixed:
- Needing more patients in combo P3 to show statistical power? A decent high school math student could have gotten that correct the first time. So dropping to MDR-2 from MDR-3 to speed up enrollment for the additional patients doens't impress me there. Should have been negotiated correctly to begin with.
- Three months of stability for 700mg instead of six? Once again, doesn't impress me. As soon as the FDA started asking for data on safety and efficacy for 700mg - well more than six months ago - the company should have started creating the stability data to ensure that we had it ready to go if necessary, not waiting to see and creating another potential delay to the BLA.
You, and many others here, know where I stand with this drug and my investment. I'm all in, pot committed. But the accumulated small failures of our management has have worn out their welcome with me personally.
On a side note, nobody should be surprised that there's selling pressure to $0.26. That's the easy (incorrect, but easy) economic cost of the shares from the tender offer that are coming unrestricted right about... now.
Should the FDA have simply allowed 350mg? Absolutely. No question whatsoever. But we can't count on the FDA to be on our team, the company has to be its own advocate. And while the company has done that effectively on several occasions, it's always after the fact. NP got the FDA to agree to reduced requirements on this, or more lenient enrollment requirements for that... but always after we should have already been done with whatever it is we're getting fixed:
- Needing more patients in combo P3 to show statistical power? A decent high school math student could have gotten that correct the first time. So dropping to MDR-2 from MDR-3 to speed up enrollment for the additional patients doens't impress me there. Should have been negotiated correctly to begin with.
- Three months of stability for 700mg instead of six? Once again, doesn't impress me. As soon as the FDA started asking for data on safety and efficacy for 700mg - well more than six months ago - the company should have started creating the stability data to ensure that we had it ready to go if necessary, not waiting to see and creating another potential delay to the BLA.
You, and many others here, know where I stand with this drug and my investment. I'm all in, pot committed. But the accumulated small failures of our management has have worn out their welcome with me personally.
On a side note, nobody should be surprised that there's selling pressure to $0.26. That's the easy (incorrect, but easy) economic cost of the shares from the tender offer that are coming unrestricted right about... now.
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