We don't know about the early look. One good reason for this may be that PPHM and their new partner/owner will want to discuss this and work it out with the FDA together. An early look is not all that uncommon. I expect we will see it. I follow a lot of biotechs and I don't know one that provides this type of information until they have worked it out with their partner and the FDA. It is not a matter of shareholders being kept in the dark. It is standard business practice. There are many on this board who are attempting to micro-manage PPHM. I prefer to leave it to SK and Dr. Garnick who have excellent training and accomplishments.
I agree and have stated a similar point of view earlier. Either the FDA is trying to give the impression they are approving trial while really helping BP by not giving early lookin. IMO for Garnick to say the EOM2 meeting was very benign tells me either they didn't ask for the lookin or the FDA is giving them something else for something else (BTD for breast/other). Otherwise, I would have thought the no lookin would have caused some contention. You would think Garnick at least would have mention the lookin and why it wasn't given.
I appreciate your contribution to this board as your knowledge in your writing is very clear and easy to follow. What worry me is the group of posters are not challenging you and I don't understand Why?
This is indeed troubling and lends support to the theory that the FDA is in the pocket of some big BPs and are working in cahoots to slow Bavi's progress. With bavi's demonstrated safety profile and extraordinary MOS results achieved in 2nd line lung (pre or post dose switching)it is hard to understand why there would not be some type of accelerated or even immediate approval contingent on follow up phase three confirmative work. By granting only regular approval for the phase three trial the FDA has provded themselves with the needed cover to protect against accusations of corruption while simultaneously achieving the goal of slowing bavi's progress significantly IMO.
ststepensrevenge, wow almost broke my fingers typing your handle :)
I think your estimation is completely off.
1) On Sept 7th PPHM still had to get a PIII and planned a FDA EOP II meeting. That meeting for sure has been delayed but we don't know exactly how long. That part you can add to the delay calculation but remember that we already have our PIII design approval now and we are only and we are only 10 after Sept 24th.
2) The delay is the internal investigation. So the time lost between the current FDA PIII approval and the one we would have got without the discrepancy case is about 3 to 6 months. It may even be that given the discrepancy case the FDA look into this trial with priority to get it of the table!
3) No AA or no Breakthrough or No early look in fall in the same category. For BTD you cannot say whether we still get one or not because it is an independent procedure for which you don't even need PII results and CSM cannot have impacted that. Even a 60% MOS and the so maniest confirmation of safety would have looked good for a BTD. And in all cases to claim any of these as delays you must show that without the discrepancy case we would have got them FOR SURE which is something we can't say.
4) As for the early look-in more specifically. Given the discrepancy case I would, being PPHM, in any case want a stick behind the door. They are under NO obligation to tell us. This CT feature is no material even on its own. In their position I wouldn't tell the public because it has some advantages not to tell:
- it will make people with bad intentions think twice before trying something if they don't know if there is going to be someone looking into this trial at a moment they don't know.
- it is a time bomb above the heads of all speculating on the short side. After the initial 100+% MOS improvement and the conservative 60% presented to the FDA nobody doubts that the PIII will have good results.
- It is a double blinded trial. I take from this board that understood that SK/Garnick must have suggested an early look-in but I didn't know that was possible. Actually it isn't really blinded anymore at that moment and if we also want all tra-la-la about people being cured because of the placebo effect of the table then it is better that we do not look in. If you announce very good or very bad interim data you never know how it will impact the patients still or in future treatments of the trial.
- Last but not least PPHM takes these 600 patients trial to have a large sample world wide and they know they either will have the cash from some partner or from another event we don't know about yet. They may start it alone to keep the pressure on the kettle but they won't go it alone.
...but as usual we are kept in the dark.
I am as annoyed with that as you at times but companies want to say the least possible.
1) it keeps their hands free to change policies without investors claiming they made decisions based on companies statements while then the company changes them for apparently no reason.
2) the industry is watching, PPHM isn't alone their. The less they say the better from where they stand.
3) trials and partnership negotiations are still going on. You may not want to play all cards in the open. Negotiators also read your PRs.
SO my personal take is that we will have lost about a year, a bump in the road as said Garnick, that we had some reputation loss with Wall Street that will be recovered when the trials are settled and dismissed the coming period. The industry knows exactly what is going on and understand the science a hundred time better then we do, they know since long there is no real problem with Bavi and that PPHM couldn't have prevented the dose switching even if it wanted.
If you want to mark that 1 year delay up to 3 to 4 years then that can only when you show we would for sure have received an AA, did ask a look in but didn't get it because of the discrepancy case (Garnick said FDA talks went swift and smooth without any problems) and that we applied for BDT and didn't get it because of CSM or will not get it in the future because of CSM, which is very unlikely.
Sorry that I have to conclude it like this, but this is the type of arguments some often hold the other way around. I know of course that you can't come up with the above because it is momentum! Tomorrow we may get a BTD or later it may show we didn't get a look in because it was either 600 or 900 patients with look-in or so and that the discrepancy case wasn't in it for anything. Don't forget, NSCLC is an important cancer not a niche. FDA will want to be sure.
Now the good news is that if what you claim can be proven by you then PPHM can for sure prove it too and use it for the settlement talks because they on top have a number of the above answers that you don't have!
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