I believe in balance as well but I like to take on the critical side to test the quality of a stock to see what the risks are and how strong the long's thesis in their position and DD. For disclosure, you are not short on this stock? I have yet to implement a buy and this remains in my watch for now. But to support TIL technology validity, I have yet to see a cancer vaccine that produce ORR results comparable to TIL and PD1/PDL-1. I agree that ADXS may have the best platform for cancer vaccine, but I still want to see how far TIL can go and more options for patients is better. Also, for preclinicals, I do like to see data in mice where 100% of mice tumors disappear.
J&E, I enjoyed your analysis of ADXS and decided to make an intial investment in it. I'm not sure why you are here trying to discourage investors of LBIO. I'm not arguing against your logic, but I'd still like to see the final results of this TIL technology esp in combo studies to see if it enhances the ORR percentage to be greater than 50%. Early results of TIL is very promising- more than cancer vaccines in melanoma have EVER done so far. T-VEc I'll wait for their combo trials with PD-1 agonists. Also, to comment on the chance of success for ADXS on their prostate collaboration with the PD1 mAb is probably small esp due to the fact that prostate cancer esp the MCRPC is resistant to PD1 therapy so far and there is very little known about ADXS-HPV results even in preclinical trials using such combos that I can find. Maybe you can enlighten us on the ADXS MB. I only saw so far in my DD that the preclinicals in mice used radiotherapy and ADXS to show 60% success vs 10% using either alone. So is this MERCK taking a shot in the dark to take this to pI without any preclinical trials?
Motley article on Agen this weekend. More publicity for Agen.
Surprised that so many experts here can't even answer your simple question. It is autologuos PBMC and not what you thought of as unpulsed DC. And you should also know that even the placebo patients are still getting pulsed DC prepared by Cognate because of the trial cross over design upon progression.
Hi DT, I wanted to ask you how TA would have helped you stay long on Jazz from hindsight. I always thought that TA was useful for short term trends but news and institutional support will determine the long term outlook and movement. Even in DVAX, I can see using TA to trade in and out on short term fluctuations, but news will move it dramatically in a direction that will break or support TA movements. TIA
Actually, BBallgm, you are the one sounding a little foolish and naive with very little understanding of this field. CLDX was good news for not just CLDX but for the entire immunotherapy and cancer vaccines including NWBO.
They can't even spell "poisitive" correctly! IMO both Zack's and The Street need to get out of biotech valuation because they don't understand it and misapply their metrics.
I can't argue against your logic. Just that some (including me) expected some better news in regards to GBM so that aldoxo might have gotten maybe an early AA for this indication before the pIII STS trial concludes. Oh well. Know of any other catalysts the rest of this yr for CYTR?
It's called planet Earth. Try reading the clinicaltrials.gov website to see what their primary and secondary endpoints were supposed to be and try to see where a pathological CR fits in. If anyone is being disingenious, it may be the company. Not my problem nor the company's if you don't know the difference between pathological and radiological CR in terms of significance in a clinical trial. And I believe I stated that pseudoprogression can show disease progression on a scan but will later be dramatically reduced and even disappear DUE to SOC and not necessarily Aldoxo but we will never find out because most likely both patients w/ the PATHOLOGICAL CR got resected again to alleviate their symptoms that was getting worse (therefore the investigator was able to get a pathology work done on those lesion samples). If a CR determined by a scan according to RANO criteria as the PRIMARY ENDPOINT specified is found, then there would be no need for a resection and pathology work (obviously) and this trial would be more promising to study further because there would be no need for excuses like pseudoprogression etc to blame for a lack of a positive ORR results. JMHO
The main point I was making is that the real issue is not whether aldoxo crosses the blood brain barrier or not, but whether aldoxo once it crosses the BBB if it does anything that is measurable according to their PRIMARY endpoint as listed on the clinicaltrials.gov site. From all their latest "positive" PR on GBM and aldoxo, I read it as FAILURE in GBM because they FAILED to show a single ORR result which is the primary endpoint. Some tumor shrinkage and stable disease in some patients and 2 pathologically confirmed CR = Zero ORR unfortunately. This was a good shot at GBM, but the company needs to move on to something else and not try to prop up sp with these PR by "fooling" naive investors. Isn't this one of the criticism against management not too long ago? JMHO and I do expect eventual approval of aldoxo but how much excitement will a better chemo generate among investors?
Don't be fooled by the company Press release. A pathological CR is NOT the same as a radiological CR. It is the radiological CR that would be most meaningful clinically imo. Thnik about it. Taking biopsy is not the best way to determine if a therapy is working or not. Also, this trial is trying to exclude pseudoprogressive patients thru their inclusion criteria of waiting at least 3mths after SOC. Maybe some psPD patients need a longer time to resolve, but the investigator can't assume that any of these patients are psPD. From what I understand, usu. these psPD patients will have scans that show initial growth of lesions to define them as progressive disease but later scans (3+mths) show those same lesions start to decrease or disappear thus indicating them to be pseudoprogressive. Heck, one can even claim that those two pathologically CR patients were the pseudoprogressive patients so the pathology report may mean that the necrosis is due to SOC and not aldoxo esp considering that they did not even bother to determine if aldoxo made it into the tissue. Another problem is the drop out rate in this trial (78%) which is way too high. Why did they drop out? Their scans probably showed that their lesions were still progressing AND their QoL was not improving or getting worse. Maybe those patients were getting better but the side effects of aldoxo was masking that improvement in QoL, and all the progression is due to pseudoprogression, but at the end of the day, did this trial show a single ORR result? ZERO from what I have read and the company is now making sure to include in their press releases that their claimed cr is a pathological one and not the RANO determined CR or even PR which is the PRIMARY endpoint for this trial.
Personally, I do believe that aldoxo is better than doxo and it should get approval but this "hype" in gbm is just that- "hype" JMHO
Maybe the reason why it moved up was because of some positive news in the biotech sector esp PBMD. Look at their market cap of 250mm and ours which is less than 50mm and our DC vaccine is further than theirs in development. Someday, we should hope to see a move like PBMD that is more sustainable. imo
Long, you are right. Only thing you sort of left out was that a lot of people are waiting for the final results at the end of this month to CONFIRM the interim results that you posted. IF it confirms these results (as most expect) then we can expect an FDA meeting for AA approval submission and hope that the interim analysis for their pIII confirmatory trial in nGBM will go well (and maybe even stop for efficacy though that would be hoping for too much)
How would you compare CLDX value vs what happened w/ PCYC in terms of mc value upon a buyout scenario assuming AA in rGBM and full approval in nGBM as well as the other pipeline in CLDX? Just trying to surmise what value a buyer might put on CLDX.
I have a high respect for Andrew Gengos. I thought he did an excellent job in the presentation and his answers to the questions gives me more confidence that their pIII trial will succeed. I wonder who asked that first question in regards to 1000 gbm patients only in the US. I wonder where he got that misinfo from? I wished he had expounded on the pI trial in the rGBM w/ ICT 121.