PPHM ASM 16th OCT 2014
Home Sweet Home :) I posted a quick report on the ASM last week and will now post one here (with an AZERTY keyboard and a screen worth that name :) because I didn't take my laptop with me.
For starters I thought the Q&A would be recorded too but that is apparently not the case. The report will be very short because I would qualify this ASM as a non-event, it actually could as well not have taken place.
1) As I predicted, a lot of Orangutan chest-knocking and driving people to hostile ASM/BoD action, but at the ASM nothing then well behaved polite people and ZERO incidents. Just so you can all place several of the agitation posts of the past 6-8 weeks. Apparently well coordinated, some dropped large amount of shares during the ASM (as seen later on the charts) while everyone was attending or must have been listening to the broadcast. But as we saw the following days, it ended up as a splash in the water and always will.
2) There was a newcomer, they guy that did the presentation in Italy, Worsley. And Garnick was there, which you all know because he was on the recording too. So that kills all the cowboy stories and doom scenario's which were clearly part of the agitation tactics of the last weeks/months.
3) SK was confident BUT not dynamic. I think he must be seriously over-worked/tired. Anyway, confidence is all I need and I hope they are again doing their day-jobs at night. Could be because the Worsley guy said they are talking with potential partners. I don't remember his exact words, it was in the Q&A, but he did NOT use the word 'collaborations' but used 'partners', in PLURAL, and did NOT say 'looking for', 'searching','finding','hope to', etc but stated it as 'factual' that they were talking.
4) Now, having an updated image of CK, I can say that I am almost sure he was at NYAS when Brekken answered the question of the 2nd ln NSCLC results being BETTER then officially filed with the FDA with a 'YES' reply. When Brekken looked at Shan, Shan before nodding back looked at an older guy next to SK - which I thought was a lawyer or so - who nodded too, after which Dr. Brekken answered the question. It was therefore also CK that said to SK : "Now they are coming for you!".
5) While SK's presentation clearly showed that these guys are working hard, must be under a lot of stress, and probably don't have much sleep, Garnick's and Jeff's were certainly full of energy. I will now as a general impression say something about those presentation as a whole, because I came to the conclusion we have been played (not badly but certainly played):
There is one, and only one, message that was embedded in the complete ASM and that message was:
The SUNRISE trial (2nd ln NSCLC PIII) is on track, will be a success but will not be finished before DEC 2016 with commercialisation for 2017.
It started with SK that talked about commercialisation in 2017 (He didn't say it like that but I remember that when he said the phrase I thought by calculation 'that is 2017 then'. In the Q&A he somewhere inserted that he believes SUNRISE is going to be a success.
Garnick almost prepared us for an FDA exam. This was not shareholders-grade but room and time filling, emphasizing how long all this FDA stuf takes. And Jeff added all the other obstacles more specific to 2nd ln NSCLC and again pointed out what a big effort all this is. He claimed there were more then 144 clinical trial sites, but I saw only #145 added recently while I was under the impression he was speaking about more then 150. Anyway, the general idea was again; it is a lot of work and you cannot speed this up. It also conveyed that these guys know exactly what they are doing. Experience and skill demonstration was all over the place. For a moment I thought they were indirectly messaging to someone: Don't think we don't know how to do it on our own!
But NOTHING on early look-ins. Quite amazing for such a detailed session on SUNRISE and FDA approval procedures. Now, remember, we learned about the TWO early look-ins by a slip of the tongue of Shan (otherwise I am under the impression we would not have known) and something tells me they would prefer we forget about them. And we alos know from the installation of a data-monitoring committee from clinicaltrials.gov and not from PPHM in the first place. I'll go even a step further, I was under the impression that all presentations and the Q&A aimed for that same goal, telling us: "DEC 2016 is DEC 2016."
They will also not update us on progress of patient enrolment AT ALL. We'll have to wait until they are all enrolled. That also means that WHOEVER makes a statement about number of enrolled patients (such as someone saying 25) is complete nonsense because PPHM doesn't give out ANY information on it and it is virtually impossible that someone would be in contact with all 144 centres to be able to name a total. And if such party exists it would demonstrate an ABNORMAL level of interest in our SUNRISE trial, wouldn't it, certainly for a drug first qualified as a placebo or a drug of which such parties later claimed it will not pass PIII, as they claimed it would not pass PII, etc
And simulations of enrolment, including mine, are only simulations, yet I believe in my Q2/2015 for some possible early SUNRISE news, certainly now that I have the feeling to be told not to believe in it. We also know there is a 200 patient increase in the bavituximab safety database and the larger part of those patients must be SUNRISE patients given the date at which the more then 400 and the more then 600 statements have been made.
Therefore, for me that "DEC 2016 is DEC 2016" impression does not really fit with something else they said (hence the word "impression"). They seem to have a SUNRISE promotion team. PPHM people that make active visits to promote enrolling in SUNRISE. They also claim there is no lack of patients for 2nd ln NSCLC. So combining those two things and having 144 (145 now) centres I have a hard time to believe we would only end enrolling in DEC 2015 and get results in DEC 2016, which would result in commercialisation in late 2017 (FDA has 2-6 months and we may have to pass before a commission - another 4-6 months) depending on our SUNRISE p-value. And it would be completely ignoring the two look-ins and only make statements based on the officially listed EOPIII in DEC 2016.
So the only thing I got out of this is that I will never again think of a BLA as a document in inches but as of now think in feet (Garnick claims - and they had slides and it was written explicitly on them - that this is an electronic document at this time but is 500.000+ pages long. I wonder if this is not a mistake ('or I mis-understood that). But it makes me appreciate having a Fast Track because PPHM can already provided parts of the BLA to the FDA and discuss them. It contains also pre-clinical data and stuff and not just PIII results. As I understood it the BLA must contain all the previous stuff (PC, PI, PII, etc too).
The Q&A questions were mostly answered by SK who kind of pulled the questions to him and by times allowed the others (eg: Shan, the patent women, etc) to additionally comment. Ebola only came up once in the Q&A and I don't think PPHM has any active plans with it besides telling they have something that could go into a cocktail. I am not sure but I think SK said in some way that they would let the initiative to others (I suppose the gov, mil or a BP or so) and that they (those others) must take the lead. I am however not completely sure on what exactly he was trying to say, but that is how it came across.
There was nothing more in there that we did not already know or that isn't in the above text. And no slips of the tongue this year :)
As a conclusion I would say that this ASM will stay in my mind as one sentence and that is that we must believe, for one reason or another, that "DEC 2016 is DEC 2016" and that it is quite important to them that we do believe that.
