Wednesday, October 22, 2014 4:28:10 PM
Peregrine ASM 10-16-2014: Slides, Audio-Link, Attendee-Reports
…Attendee Reports at the end, after the 42 Slides…
Peregrine ASM 10-16-2014 (webcast+slides: S.King/J.Hutchins/R.Garnick)
AUDIO REPLAY (1:06): http://www.media-server.com/m/p/esce8gvh
Form 8-K 10-16-14 (Voting Results): http://www.sec.gov/Archives/edgar/data/704562/000101968714003889/peregrine_8k.htm
42 SLIDES ( http://www.peregrineinc.com/images/stories/pdfs/asm_2014.pdf )...
10-16-14 PEREGRINE ASM – ATTENDEE REPORTS:
By: Um-Tiger 10-16-14 8:57amET iHub #194227
• From what I understand, enrollment is more like a bell curve than a hockey stick. The inflection point is now with 145 sites up and running. 160 is their goal in case some centers don't enroll. It slows down when they get over 500 patients b/c they don't want more than 600 patients so it would end the bell curve. King & Shan are visiting some of the sites. Not all but as many as they can. Most if not all of the doctors said they have never seen management visit the center. It was encouraging. They are trying to enroll as fast and as many as possible. There are 2 look-ins next year. The first one is in the Spring and it is to see whether the safety and efficacy is good. Basically, a Go/No Go. The 2nd look-in will be Q4 2015; that will be about stop the trial (MOS & P-value) or continue on. The trial will end around Dec 2016. All of this depends on the enrollment and how quickly patients; sadly pass. So, we are 13 or 26 months away from seeing results.
• Ebola was talked about a lot. The PR yesterday was worked on/submitted back in February and now it is out. Not holding my breath; but something could be brewing for Ebola. Money is there from Gates, Zuckenberg and Gov't since it is becoming a national crisis. Need to combo like with interferon or something similar.
• Liver & Breast papers are coming from the doctors... Yopp & Allison Stopeck soon. In order of importance are Lung, Breast, Liver and Melanoma trials. Liver could leap frog breast if results are really good. Liver is encouraging and wouldn't be surprised to see an Asian partnership for Liver cancer. Not holding my breath but seems to be the best bet at the moment.
FU/194234: No...it is all event driven. I guess I should say they are guestimates on when the look-ins will be from management. They will PR when enrollment is complete and that is it. No half way or ahead of enrollment PR, just enrollment is complete. Just said enrollment is going good and they expect it to be complete by end of 2015. King & Shan visiting they believe has helped enrollment.
FU/194772: The dates to focus on are Dec2015 and Dec2016. I spoke to SK and he said the 2nd look in would be in Q4 of 2015. He was not holding his breath, but would love to hit jackpot. He was focused on Dec2016. He also said if Dec2015 came back at p-value 0.05, they would probably let it continue on. P-value would have to be significant lower than 0.05 to stop the trial. He is focused on Dec2106.
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By: Robert C Jonson 10-16-14 9:20pmET iHub #194231
Re: your, "He has done this [steer a drug through the approval process] with 17 other drugs", Carlton Johnson said he's done it with 20 other drugs and he hoped strongly that Bavi would be his 21st.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=107283659
FU to CP/194743: “Re: enrollment numbers, SK said how well our enrollment is doing would be indicated by our interim look-ins; i.e., better enrollment means earlier look-in. Garnick also said the Holy Grail of Sunrise would be to get a priority review. I was also interested to learn we might ask for a BTD if the data supported it and if it were clear that a BTD would help with the approval process, but it is not a given that getting a BTD would be helpful, which I hadn't known.
By: Hawkfan1 10-17-14 11:20amET iHub #194332
Hi, guys - Got back from ASM too late last night to post. And UM-tiger did a very good job of posting one of the conversations with SK that I heard. Attendance was lighter this year than in past years. It was fun to see a lot of familiar faces, though. Anyway, here's a few of the Q&A comments. Not 100% inclusive of all of the questions, 'cause I couldn't write fast enough to get them all...All questions & answers are paraphrased from my notes to the best of my ability...
Andy - When the trial sites open, do they already have patients to treat?
SK - They start screening after the site opens.
Andy - Are any of our collaborations in the viral area?
SK - Yes, we have some in viral.
Safrong - Do we do anything to let patients know about our trial?
SK - Given the number of sites, the patients are there. We just need to make sure that they get into our trial.
Joe - We do have a program of company employees that go out to the sites to meet with the doctors and tell them how excited we are about our trial.
(see UM-tiger's post about Steve and Joe going to as many sites as they can.)
Bob - If data warrants it, would we apply for breakthrough designation?
SK - If it helps speed things up, yes.
Rob -It depends on the data. If data p value is 10 to the minus 9, there won't be an ODAC meeting. If the p value is .048, that guarantees an ODAC meeting. Breakthrough Designation is for companies with stunning data. Because of phII we're not there yet, but if phIII warrants it, yes, we'll go for it.
Brandon - Can you comment on Ebola?
SK - Ebola should be studied, and we are pursuing that. The government should be leading the way. There are only about 4 or 5 places in the US where Ebola can be studied, and the government has them all. We want to be involved.
Brandon - When we lost the DTRA contract, my understanding is that it was because there was not a single dose that was consistently effective? Is this only true in Ebola?
SK - Part of the problem was that viral moves so fast. Based on our current knowledge of the mechanism of action we can apply it differently now.
Safrong - Is there any update on the imaging trial?
SK -It is progressing very nicely. Part of the problem is that cancer patients don't want to be in and imaging trial when they can be being treated for cancer, but it is moving along nicely lately.
Brandon - Are IL2 and interferon possible combinations for Ebola?
SK - Yes, along with several others.
Bob - How long before we hear about Betabodies?
SK - It's in the preclinical pipeline - not a big focal point, but moving.
Andy - Is there a problem with the Betabodies patent?
Shelly - No problem. Remember, the first action is usually rejection, which caused a slight delay in the US. In the EU we have been hopeful that if we wait a bit, we will be able take advantage of pending legislation to save several hundred thousand dollars. (in a side conversation, she explained that currently, to get European patents, you have to get approval in each individual country, which can cost half a million dollars, but there is legislation (already approved, they're just ironing out the details of where the head offices will be) that will allow you to file once for approval in all EU countries. That could save us upwards of $400,000, so they are waiting for a couple of months).
Vicky - Can the EU approve Bavi independent of the FDA?
SK - Yes, they are independent processes, we will file in both places.
Randy - How do you connect a KOL to the drug approval process?
SK - Drug approval is a government process, and the government doesn't have experts in every field. KOL's could go to the ODAC meeting. KOL's help in overall general acceptance of a drug.
Rob - KOL's help recruit patients to trials. KOL's and patient advocates will be at the ODAC meeting. But where KOL's really help is after the drug has been approved, and is on the market, by getting doctors to use your drug.
Bob - Will we get a PR when half of the patients are enrolled in Sunrise?
SK - I don't think so. (Later Chris K. said that we would definitely get a PR for total enrollment.)
Andy - Any progress on Dr. Stopeck's paper?
SK - The process is extremely variable. It takes a long time to complete the review process.
Safrong - If the government is working with Bavi and ebola, and they want to buy a bunch of Bavi, can we supply it?
SK - Yeah, it's available. We're waiting by the phones. (Said tongue in cheek)
Brandon - Are we building out Avid?
SK - We believe Sunrise is going to be successful, so we will need to be able to meet that need, and also, Avid has a growing customer base.
Unknown - Do we have any potential partnerships?
Steve Worsley - Yes, we are in active discussions.
One other comment in regard to the post that Um-tiger made about early look-ins. My understanding is that the first early look-in is to look for adverse events and signs of efficacy. If there are too many adverse events, or no signs of efficacy, the trial will be stopped, but early approval is not a possibility at first look-in. Second look-in is when we have a chance at early approval. SK indicated that we are about where they expected to be in terms of patient enrollment (not ahead, not behind, but on track for full enrollment by the end of 2015) and they are expecting (guessing) that that is about when we will have enough events (deaths) to get the 2nd look-in.
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By: Copper888 10-17-14 1:33pmET iHub #194365
I will add only a few points to Hawk's excellent recap. First, I would estimate that there were about 30-35 stockholders in attendance. There were a few questions on the circumstances in which the trial would be stopped early, ethical reasons, etc. It was made very clear from Shan that nothing can happen or will happen until the trial is "unblinded".
As far as Ebola is concerned, the attitude that I observed from King was that Bavi is a "no brainer" and should be included in any discussions as to the treatment of Ebola. However, there didn't seem to be any plan as to how to advance this idea to the "powers that be" outside of the Company. Taken at face value, it struck me as a very passive approach.
There were no questions concerning the stock price, performance, Exec & board comp, etc….no airing of grievances.
As a side note, Dr. Hutchins, who got pilloried in the comments here during his speech, was actually the most passionate and truly excited speaker there (Garnick was strong as well). I guess it didn't translate to the listeners not in the room.
Just wanted to provide a little "color". We need to have more people there in the future as the group seemed very willing to discuss what they could. It would have been nice to hear alternative points of view and challenges, only to hear their responses to them. Is there some fight in this dog?
Staying very LONG and strong! Good Luck to All EOM
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By: Holotawoopas 10-17-14 2:01pmET iHub #194377
I was at the ASM. I asked SK if Dr. Garnick's power point pres. would be available on the web site - SK said it would. I needed to see & hear Dr. Garnick explain the reality of the approval process both pros & cons so that I could put in check some if not all of the expectations of this process being a near term catalyst for share price appreciation. The communications I observed seemed to me to be upbeat and gave me the impression PPHM is comfortably on track with their overall business plans. The only thing that will increase PPS IMO in the near term is hype based on new data or publicly announced agreements of any ongoing talks. I did talk to Dr. Garnick after the meeting, but got nothing more about the approval process that was already given.
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By: CloakedProtector 10-22-14 6:24amET iHub# 194738
…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 presentations 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 commercialization for 2017. It started with SK that talked about commercialization 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 stuff 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 than 144 clinical trial sites, but I saw only #145 added recently while I was under the impression he was speaking about more than 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 also 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 centers 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 than 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) centers 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 commercialization 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 2 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 misunderstood that). But it makes me appreciate having a Fast Track because PPHM can already provide 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.
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FU TO EDCPF/194747 :
You must have missed the sentence in which I wrote that I stick to my simulation and believe for SUNRISE news in Q2/2015. You are confounding the IMPRESSION that I write about that PPHM wants us to focus on DEC 2016 as EOPIII (throwing over board all look-ins, DMC's, faster enrolments, etc, etc) with what I personally believe. In other words they probably figured that when we stick to the DEC 2016 date we will not be disappointed, even if they come up earlier BUT certainly not later. I myself think exactly what you have been writing and I thought my post made that clear. What is strange is that they simply didn't bring up the interim/early look-ins at all while I assure you Garnick's presentation was VERY VERY detailed and precise on the complete approval procedure.
Re: your, “Can you confirm another poster's information from Q&A that the first look-in will definitely not be used for trial stop (safety only), however the 2nd one can be used for that?”, No I cannot not. As far as I recollect look-ins have not been mentioned, but I can be wrong. I could have been distracted although there wasn't the kind of people that could distract me :)
Re: your, “Q&A: No PR for half enrollment?”, I didn't hear that, but possibly this is a rephrasing of NO UPDATES ON PATIENTS ENROLMENT (AT ALL). This would qualify as no PR for half enrolment, wouldn’t it?
By: Ku 10-22-14 11:22amET iHub# 194771
Ecpf, I was at the ASM. The study is not going to be stopped before look-ins for ethical reasons (great result) because the DMC does not have access to the data and will not until the first look-in. However, Shan said that there will be 2 look-ins at the data by DMC and left it at that. IMO they can get approval before the end of the study, but have to continue at least the bavi arm to the end.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=107434341
…Attendee Reports at the end, after the 42 Slides…
Peregrine ASM 10-16-2014 (webcast+slides: S.King/J.Hutchins/R.Garnick)
AUDIO REPLAY (1:06): http://www.media-server.com/m/p/esce8gvh
Form 8-K 10-16-14 (Voting Results): http://www.sec.gov/Archives/edgar/data/704562/000101968714003889/peregrine_8k.htm
42 SLIDES ( http://www.peregrineinc.com/images/stories/pdfs/asm_2014.pdf )...
10-16-14 PEREGRINE ASM – ATTENDEE REPORTS:
By: Um-Tiger 10-16-14 8:57amET iHub #194227
• From what I understand, enrollment is more like a bell curve than a hockey stick. The inflection point is now with 145 sites up and running. 160 is their goal in case some centers don't enroll. It slows down when they get over 500 patients b/c they don't want more than 600 patients so it would end the bell curve. King & Shan are visiting some of the sites. Not all but as many as they can. Most if not all of the doctors said they have never seen management visit the center. It was encouraging. They are trying to enroll as fast and as many as possible. There are 2 look-ins next year. The first one is in the Spring and it is to see whether the safety and efficacy is good. Basically, a Go/No Go. The 2nd look-in will be Q4 2015; that will be about stop the trial (MOS & P-value) or continue on. The trial will end around Dec 2016. All of this depends on the enrollment and how quickly patients; sadly pass. So, we are 13 or 26 months away from seeing results.
• Ebola was talked about a lot. The PR yesterday was worked on/submitted back in February and now it is out. Not holding my breath; but something could be brewing for Ebola. Money is there from Gates, Zuckenberg and Gov't since it is becoming a national crisis. Need to combo like with interferon or something similar.
• Liver & Breast papers are coming from the doctors... Yopp & Allison Stopeck soon. In order of importance are Lung, Breast, Liver and Melanoma trials. Liver could leap frog breast if results are really good. Liver is encouraging and wouldn't be surprised to see an Asian partnership for Liver cancer. Not holding my breath but seems to be the best bet at the moment.
FU/194234: No...it is all event driven. I guess I should say they are guestimates on when the look-ins will be from management. They will PR when enrollment is complete and that is it. No half way or ahead of enrollment PR, just enrollment is complete. Just said enrollment is going good and they expect it to be complete by end of 2015. King & Shan visiting they believe has helped enrollment.
FU/194772: The dates to focus on are Dec2015 and Dec2016. I spoke to SK and he said the 2nd look in would be in Q4 of 2015. He was not holding his breath, but would love to hit jackpot. He was focused on Dec2016. He also said if Dec2015 came back at p-value 0.05, they would probably let it continue on. P-value would have to be significant lower than 0.05 to stop the trial. He is focused on Dec2106.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=107284074
By: Robert C Jonson 10-16-14 9:20pmET iHub #194231
Re: your, "He has done this [steer a drug through the approval process] with 17 other drugs", Carlton Johnson said he's done it with 20 other drugs and he hoped strongly that Bavi would be his 21st.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=107283659
FU to CP/194743: “Re: enrollment numbers, SK said how well our enrollment is doing would be indicated by our interim look-ins; i.e., better enrollment means earlier look-in. Garnick also said the Holy Grail of Sunrise would be to get a priority review. I was also interested to learn we might ask for a BTD if the data supported it and if it were clear that a BTD would help with the approval process, but it is not a given that getting a BTD would be helpful, which I hadn't known.
By: Hawkfan1 10-17-14 11:20amET iHub #194332
Hi, guys - Got back from ASM too late last night to post. And UM-tiger did a very good job of posting one of the conversations with SK that I heard. Attendance was lighter this year than in past years. It was fun to see a lot of familiar faces, though. Anyway, here's a few of the Q&A comments. Not 100% inclusive of all of the questions, 'cause I couldn't write fast enough to get them all...All questions & answers are paraphrased from my notes to the best of my ability...
Andy - When the trial sites open, do they already have patients to treat?
SK - They start screening after the site opens.
Andy - Are any of our collaborations in the viral area?
SK - Yes, we have some in viral.
Safrong - Do we do anything to let patients know about our trial?
SK - Given the number of sites, the patients are there. We just need to make sure that they get into our trial.
Joe - We do have a program of company employees that go out to the sites to meet with the doctors and tell them how excited we are about our trial.
(see UM-tiger's post about Steve and Joe going to as many sites as they can.)
Bob - If data warrants it, would we apply for breakthrough designation?
SK - If it helps speed things up, yes.
Rob -It depends on the data. If data p value is 10 to the minus 9, there won't be an ODAC meeting. If the p value is .048, that guarantees an ODAC meeting. Breakthrough Designation is for companies with stunning data. Because of phII we're not there yet, but if phIII warrants it, yes, we'll go for it.
Brandon - Can you comment on Ebola?
SK - Ebola should be studied, and we are pursuing that. The government should be leading the way. There are only about 4 or 5 places in the US where Ebola can be studied, and the government has them all. We want to be involved.
Brandon - When we lost the DTRA contract, my understanding is that it was because there was not a single dose that was consistently effective? Is this only true in Ebola?
SK - Part of the problem was that viral moves so fast. Based on our current knowledge of the mechanism of action we can apply it differently now.
Safrong - Is there any update on the imaging trial?
SK -It is progressing very nicely. Part of the problem is that cancer patients don't want to be in and imaging trial when they can be being treated for cancer, but it is moving along nicely lately.
Brandon - Are IL2 and interferon possible combinations for Ebola?
SK - Yes, along with several others.
Bob - How long before we hear about Betabodies?
SK - It's in the preclinical pipeline - not a big focal point, but moving.
Andy - Is there a problem with the Betabodies patent?
Shelly - No problem. Remember, the first action is usually rejection, which caused a slight delay in the US. In the EU we have been hopeful that if we wait a bit, we will be able take advantage of pending legislation to save several hundred thousand dollars. (in a side conversation, she explained that currently, to get European patents, you have to get approval in each individual country, which can cost half a million dollars, but there is legislation (already approved, they're just ironing out the details of where the head offices will be) that will allow you to file once for approval in all EU countries. That could save us upwards of $400,000, so they are waiting for a couple of months).
Vicky - Can the EU approve Bavi independent of the FDA?
SK - Yes, they are independent processes, we will file in both places.
Randy - How do you connect a KOL to the drug approval process?
SK - Drug approval is a government process, and the government doesn't have experts in every field. KOL's could go to the ODAC meeting. KOL's help in overall general acceptance of a drug.
Rob - KOL's help recruit patients to trials. KOL's and patient advocates will be at the ODAC meeting. But where KOL's really help is after the drug has been approved, and is on the market, by getting doctors to use your drug.
Bob - Will we get a PR when half of the patients are enrolled in Sunrise?
SK - I don't think so. (Later Chris K. said that we would definitely get a PR for total enrollment.)
Andy - Any progress on Dr. Stopeck's paper?
SK - The process is extremely variable. It takes a long time to complete the review process.
Safrong - If the government is working with Bavi and ebola, and they want to buy a bunch of Bavi, can we supply it?
SK - Yeah, it's available. We're waiting by the phones. (Said tongue in cheek)
Brandon - Are we building out Avid?
SK - We believe Sunrise is going to be successful, so we will need to be able to meet that need, and also, Avid has a growing customer base.
Unknown - Do we have any potential partnerships?
Steve Worsley - Yes, we are in active discussions.
One other comment in regard to the post that Um-tiger made about early look-ins. My understanding is that the first early look-in is to look for adverse events and signs of efficacy. If there are too many adverse events, or no signs of efficacy, the trial will be stopped, but early approval is not a possibility at first look-in. Second look-in is when we have a chance at early approval. SK indicated that we are about where they expected to be in terms of patient enrollment (not ahead, not behind, but on track for full enrollment by the end of 2015) and they are expecting (guessing) that that is about when we will have enough events (deaths) to get the 2nd look-in.
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By: Copper888 10-17-14 1:33pmET iHub #194365
I will add only a few points to Hawk's excellent recap. First, I would estimate that there were about 30-35 stockholders in attendance. There were a few questions on the circumstances in which the trial would be stopped early, ethical reasons, etc. It was made very clear from Shan that nothing can happen or will happen until the trial is "unblinded".
As far as Ebola is concerned, the attitude that I observed from King was that Bavi is a "no brainer" and should be included in any discussions as to the treatment of Ebola. However, there didn't seem to be any plan as to how to advance this idea to the "powers that be" outside of the Company. Taken at face value, it struck me as a very passive approach.
There were no questions concerning the stock price, performance, Exec & board comp, etc….no airing of grievances.
As a side note, Dr. Hutchins, who got pilloried in the comments here during his speech, was actually the most passionate and truly excited speaker there (Garnick was strong as well). I guess it didn't translate to the listeners not in the room.
Just wanted to provide a little "color". We need to have more people there in the future as the group seemed very willing to discuss what they could. It would have been nice to hear alternative points of view and challenges, only to hear their responses to them. Is there some fight in this dog?
Staying very LONG and strong! Good Luck to All EOM
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By: Holotawoopas 10-17-14 2:01pmET iHub #194377
I was at the ASM. I asked SK if Dr. Garnick's power point pres. would be available on the web site - SK said it would. I needed to see & hear Dr. Garnick explain the reality of the approval process both pros & cons so that I could put in check some if not all of the expectations of this process being a near term catalyst for share price appreciation. The communications I observed seemed to me to be upbeat and gave me the impression PPHM is comfortably on track with their overall business plans. The only thing that will increase PPS IMO in the near term is hype based on new data or publicly announced agreements of any ongoing talks. I did talk to Dr. Garnick after the meeting, but got nothing more about the approval process that was already given.
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By: CloakedProtector 10-22-14 6:24amET iHub# 194738
…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 presentations 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 commercialization for 2017. It started with SK that talked about commercialization 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 stuff 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 than 144 clinical trial sites, but I saw only #145 added recently while I was under the impression he was speaking about more than 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 also 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 centers 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 than 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) centers 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 commercialization 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 2 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 misunderstood that). But it makes me appreciate having a Fast Track because PPHM can already provide 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.
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FU TO EDCPF/194747 :
You must have missed the sentence in which I wrote that I stick to my simulation and believe for SUNRISE news in Q2/2015. You are confounding the IMPRESSION that I write about that PPHM wants us to focus on DEC 2016 as EOPIII (throwing over board all look-ins, DMC's, faster enrolments, etc, etc) with what I personally believe. In other words they probably figured that when we stick to the DEC 2016 date we will not be disappointed, even if they come up earlier BUT certainly not later. I myself think exactly what you have been writing and I thought my post made that clear. What is strange is that they simply didn't bring up the interim/early look-ins at all while I assure you Garnick's presentation was VERY VERY detailed and precise on the complete approval procedure.
Re: your, “Can you confirm another poster's information from Q&A that the first look-in will definitely not be used for trial stop (safety only), however the 2nd one can be used for that?”, No I cannot not. As far as I recollect look-ins have not been mentioned, but I can be wrong. I could have been distracted although there wasn't the kind of people that could distract me :)
Re: your, “Q&A: No PR for half enrollment?”, I didn't hear that, but possibly this is a rephrasing of NO UPDATES ON PATIENTS ENROLMENT (AT ALL). This would qualify as no PR for half enrolment, wouldn’t it?
By: Ku 10-22-14 11:22amET iHub# 194771
Ecpf, I was at the ASM. The study is not going to be stopped before look-ins for ethical reasons (great result) because the DMC does not have access to the data and will not until the first look-in. However, Shan said that there will be 2 look-ins at the data by DMC and left it at that. IMO they can get approval before the end of the study, but have to continue at least the bavi arm to the end.
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