Replies to post #261151 on Avid Bioservices Inc (CDMO)

[Carboat]

That is exactly what Garnick and company were watching out for in the first look-in. PPHM knows that there have been previous strange anomalies in control arms, and even an outright sabotage of the phase2 trial. So, the tight margin was a smart devise

The tight margin was a smart device? Th ecompany plunged 60% in value. They stopped all bavi/chemo trials. They are getting a delist letter on Monday. They will be booted from Russell funds next month. A RS is nesc. to raise more funds to keep diluting and paying exec monster salaries.
Yes, it was such a good device.
And Granick is likely gone from pphm at this point. over a month after a futility stop and no word from Chief of Regulatory - not even a quote or excerpt in a pr.

[eb0783]

In-Garnick-we-trust. eom

[Carboat]

You have a packet of 154+ patients, including a Bavi arm that has met design expectations, to submit toward the BLA.

What bla application? The one with data from the botched PII that had to have the data recast and the PII that was stopped for futility? The same trial that prompted the company to halt all other trial of bavi/chemo? Any bla ever accepted for a drug that was stopped for futility?

[ArchieK]

Now correct me if I'm wrong, but patients can opt to continue their therapy and we can actually be seeing additional data from them which would even increase the data available for them to consider? Great post Sun, I really see the stop so differently than many but not all...and when someone posts like you do I feel less queasy. GLTA.

[nh]

Thank you, Sunstar. Maybe you can tell from my posts on this aspect of the trial, I'm really just trying to understand why the tight margin was used. Just seems that if the goal was to produce a separation of the arms, then it would have been smarter to widen that margin. If the goal is to produce an early trip wire, then create a narrow one. So, we do have to conclude that it was more important to create this early 'trip wire' than to create a later, sure separation of the arms. I hate that thought, when adding a little more margin could have given greater assurance of a separation and when so much time and money had already been spent, a little more to spend for insurance would be the conservative way to do things. That's just how I think, personally. Not that it's the right way. It's just the way I think, without expertise in this field. I wouldn't want an early, false trip wire that would totally collapse the trial after so much had gone into it. Well, that is what happened, in fact. Or so it appears.

So the question becomes... WHY????? With Rob Garnick, we are not dealing with a lightweight. So that is saying to me : 'The early "trip wire" was more important than a little more insurance'. WHY????

There have been numerous theories on reasons the results of this trial will NOT be tossed away into a trash pile of failure. It stands to reason one or more of them may be correct. If not, then Rob Garnick is not all we thought he was. And somehow, I don't think that is the correct interpretation. In my mind, it has to be one or the other. It really does come down to that in my own mind. One or the other. And yes, I could be wrong even in this layman's logic, I know that. Maybe I'm just thinking out loud here.

So, your post in replying to mine has a lot of merit and I have learned over a long time to greatly respect your posts. Numerous posts by CP are held in high esteem as well. I'm looking forward to the coming days, weeks, and months to see how this plays out. I can see that there is this possibility that the trial design was in fact rather ingenious.

Thank you, Sunstar.

[Protector]

sunstar, you are top on. That is indeed the reasoning. The 154 (77+77) were acquired in FULL 100% under the double blinded standard because they evented and only then the IDMC did the look in and hence only then PPHM could unblind them if they decided to stop SUNRISE.

And from the PII Sept 7th 2012 results PPHM know you can get stat sig with 121 (41-40_40) patients on a 113% SOC beating (5.6 vs 12.1 months) while the control arm got Bavituximab. Since the salvaging we know that are REAL performances, the error was not in the calculations of the results the dose switching was a field manipulation that is EMBEDDED in the Sept 7th results. And that is the part SOME would NOT LIKE US TO REALIZE.

The sentence : YES the doses where mixed up, BUT the results were correctly reflecting the clinical trial with mixed up doses in the disadvantage of Bavituximab, hence the results were even better then those of Sept 7th 2012 seems to be hard to swallow for some.

Shan and King EXPLICITLY made statements related to the outperforming of the control arm in SUNRISE and how they pro-actively included that in the design, (text was provide). No doubt at all that the margins are about adding expectation time to the Docetaxel alone.

Docetaxel performed in a very predictable range over many years, ranges that only SLIGHTLY moved based on other care quality AT LEAST the MAXIMUM is well established at 10.4. So PPHM had a VERY GOOD BASIS to start form and to add the margin to in a worst case scenario.

We know Bavituximab has 16+months with patients of this stage/ecog (just like the control arm goes from 5.6 to 10.4 if healthier patients are enrolled. So expecting 14 months is reasonable and allows a 12 months expectation for the control arm. And as you said, the design was to achieve SOC.