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Hi Dew,
I wonder how such an effective drug in both advanced fibrosis and cirrhosis after only 16 weeks could remain so under the radar. Could 100% institution and insiders ownership be one of the reasons?
Well, we will know soon enough, with Ph1 7th cohort result in MM and 4 ph2 results in B Cell Malignancies all due in Q4 2019. Good luck with your short
What i like most about clr 131 technology is that it can make radiooncology usable also in metastatic setting so to expand its market by 10 times imo. And that pdc technology potentially applies to all oncology drugs making them safer and more effective
http://www.irdirect.net/prviewer/release/id/4042654
The meeting with the FDA is to discuss whether the 6 months interim data (which was presented in July), is enough to grant AA in addition to the cardiac and respiratory data . I guess today's additional data was necessary to complete the PUL 2.0 data with shoulder and distal at 6 months (mid level data was reported earlier)
I do not know what was presented but they are waking up in the middle of the night tomorrow to do the webcast and present/discuss the results at 5.30 am Pacific time. At least they must have some updates
Hedge Funds are shaking the tree today to get shares on the cheap. Looking forward to Saturday late breaker presentation and Monday premarket presentation and conference call about updated interim results in DMD. So do you think that on such stage they will present underwhelming results? LOL
https://endpts.com/sareptas-exondys-51-is-not-cost-effective-nor-particularly-beneficial-to-dmd-patients-icer/. Eteplirsen is basically the only not particularly effective drug for a part for patients with DMD, priced at almost $900K average per patient per year. The drug was approved based on 12 patients trial. Eteplirsen had $300M sales last year (fist full year after introduction) and $94M sales in q2 2019. I think Capricor has good chances to be approved based on the shown results and to surpass by far Eterplisen sales. Place your bets
https://clinicaltrials.gov/ct2/show/record/NCT03406780 study is active but not recrruting. FDAQ requested a type 2 meeting to decide if this trial could serve as registration trial. I guees they are meeting FDA soon and in the meantime suspended enrolment. Could you imagine what would happen to stock price if FDA decides this is enough for a BLA? Worldwide there is a potential market of 100,000 not ambuling people, at 600,000 pa. each, even a 10% market penetration would mean $6B revenue and a market cap anywhere between $30 and $50B. The company has $13M market cap now!
https://finance.yahoo.com/news/cellectar-announces-oral-presentation-european-120000188.html
Are they showing updated interim results tomorrow?
Ph2a is still ongping ... on Saturday they should present ph2a interim results for DLBCL.. Starting of PH3 seems a bit premature.. how do you come to such conclusion?
For sure they will present ph2 interim results on the 28th.
Any info on what was presented yesterday at the MM workshop?
What i find strange is that only 13 people have been enrolled and primary completion date already reached. Are results so compelling that they want to accelerate the approval path?
Why is the company engaging in so long discussions with the fda? The vaccine is safe, there are signs of efficacy in tnbc. Why don't they start a ph3 and that's it?
Cytokine release is out of question and in general excellent safety profile has been confirmed with many patients in blood cancers.
Now , regardless of epitote spreading what we want to see is ORR and PFS results. This because solid tumors immunosuppressive microenvironment is very different from hematological tumors and at the moment we do not know if what works in blood cancers can produce meaningful clinical benefits also in solid tumors. A plenary oral presentation at an important medical conference followed by a company coneference call (management has to wake up in the middle of the night to do a conference call at 8.30 Eastern time on Monday) leads me to believe they have at least some interesting results to show.
Poods, IOVA's TIL has had about 40% ORR in both melanoma and cervical cancer. CR's are much lower (around 10% if I remember well).
Pembrolizumab was approved based on ph1 study results... so if PC results are compelling, an accelerated approval is not out of question..
https://www.ascopost.com/issues/october-15-2014/first-approval-of-pd-1-inhibitor-pembrolizumab-in-unresectable-or-metastatic-melanoma/
Well proteins like pd1 inhibit t cell infiltration but you need to have those infiltrating t cells otherwise anti pd1 only won't work. So i think definitively a combination to consider expecially in melanoma.
Externally trained t cells, which once infused back into the patient are waking up and training other t cells to attack different cancer targets? How beautiful is that? Are we on the road to cancer cure?
Whatever is the reason of such increasing short interest (10 times bigger than last year and 4 times bigger than Jan 1st 2019), the strenght of the stock is demonstrated by the increasing price despite the increasing short interest
What kind of news are we expecting from the FDA?
https://www.proactiveinvestors.com/companies/news/220538/outlook-therapeutics-initiated-with-an-outperform-rating-12-price-target-at-oppenheimer-220538.html
The key part of Oppenheimer analysis is where they say 'Per agency guidance, the approval of ONS-5010 would make it illegal to use compounded Avastin'.
This means ONS 5010 once approved should take up Avastin 50% market share.
With a chance to increase price since an approved drug while getting 12 years protestion from biosimilars. That is what is behind this rally IMO. If so, there is much more to come IMO. Comments?
So private institutional investors paying market price ... hhhhm wouldn't they want to have some insights into how the GBM ph3 patients are doing before putting $6.5M into this company? Remember this is an open label trial and 22 patients have been enrolled so far. Results are due in Q3
1. They filed for a mized shelf offering
2. They announced they are starting the Stroke rial in Summer
3. They said they have cash until July
4- They said they are going to announce GBM first cohort results in summer
I guess they are going to release very good results in GBM, do a raise , partner GBM and use the proceeds to start ph2 stroke trial.
Please comment
Senti - from STUPP trial 2 years survival for INOPERABLE GBM treated with RT plus chemo is around 10%. Are there any significant differences between methylated and unmethylated turmors in terms of survival? Do you have any links? Thanks
yes it seems much better (4 times) than SOC in inoperable GBM. My guess it's because the treatment has oxygenated the tumor whilst giving radiation hence making it much more effective. My guess is that since in ph3 they are extending TSC administration also to the chemotherapy part, results could be even better than ph2. We will see
Senti, they have already started ph3 in INOPERABLE GBM (where they obtained 40% survival at 2 years in ph2) in Jan 2018. They have now finoshed the first 8 people escalation dose cohort and currently analyzing the results, which are due to be reported shortly.
abeta- you are welcome. What do you think of it? It seems that this drug and the company are completely under radar. I have never heard of 40% survival at 2 years for inoperable GBM with 30% CR, although this was obtained with only 15 patients.
Nobody is talking about it and the stock is very beaten down at $15M.
I used to be an NWBO investor a few years ago, but got discouraged by their GBM never ending trial and the not so clear CEO dealings with COGNATE.
But I wanted to put this company up for review to this Board since I know there are a lot of experts in GBM here.
Opinions about this company/trial please. Ph2 GBM 2 years survival in INOPERABLE patients 40%. 53% ORR with 30% Complete responses. Ph3 ongoing, reporting results of the first 8 patients soon. Technology applicable to basically all solid tumors . Market cap $15M. Below the link to the ph2 results
http://diffusionpharm.wpengine.com/wp-content/uploads/2016/05/20162E32Ejns152693.pdf
From ph2GBM trial ' The tumors in 27 (73%) of these 37 tumor-bearing patients regressed during this trial. The addition of TSC to the SOC resulted in tumor reductions greater than 40% in 21 of the 37 patients. Perhaps the most significant result is the complete disappearance (100% reduction) of tumor in 11 patients (30%)'. How is it possible that no BP has provided its support to advance such a brilliant drug. 57% ORR (of which 30% CR!) is unheard of in GBM. They must be waiting for the initial ph3 8 people results to get better terms , I guess.
From 10Q' Commencement of the randomization portion of the INTACT Phase 3 Trial is contingent upon our entering into a strategic partnership providing
the necessary resources to undertake the full 236 patient trial' They must be in discussions with a BP based on the first 8 patients results...
Looks like they are banking all on first 8 patients results in GBM to be reported in (early) summer. To fund their business, the prosecution of ph3 GBM trial and the start of ph2 in stroke. My guess is that they are waiting for the 1 year mark to report 1 year survival for these first 8 people.
Something does not add up.
The clinical trial link https://clinicaltrials.gov/ct2/show/NCT03393000 says that the trial is active but not enrolling.
In Jan 2019 the change the status and put the actual number of patients as 22 significantly lower than the initial plan. On the other hand they stated on March 20th in their 10k that the trial is still enrolling, and that they plan to complete the first patients escalating doses cohort in q2. So not sure what is going on here, but to me something is brewing. Any insight?
Please in the attched link ph2 GBM study detailed results. 40% of the 14 inoperable GBM patients surviving 2 years. 11 of the 59 patients achieving CR. Simply outstanding. My guess is that these results may be even improved considering the concomitant and continuous administration of TSC during the whole trial, cuopled with escalating doseage, but I would not mind if they are simply confirmed. What is more important is the proof of concept applicable to basically all cancers. This is all very exciting , we should hear about the results of the ph3 8 patients initial cohort shortly (this initial phase is expected to be completed in Q2 2019)
https://thejns.org/view/journals/j-neurosurg/126/2/article-p460.xml
Question for the board. Do we know ho many patients were biopsy only/inoperable (and achieved 40% survival at 2 years) out of the 59 in ph2 GBM trial?
Money can and will be found if TSC is effective as it seems to significantly improve survival in GBM. I struggle to understand how could DFFN be in such situation if ph2 results were legit. 4 times survival improvement and 30% Complete response in inoperable GBM is unheard of! If these results are confirmed in ph3 the company will trade above $1B for sure in a very short timeframe.
Now all we need is some first glance at the first 8 patients to see how they fare. Yesterday's jump might well be due to a leak about the results soon to be announced.
Can please somebody explain me how it's possible that a company with a drug quadrupling survival in ph2 at 2 years vs SOC in inoperable GBM, and in ph3 for the same condition is trading at $15M? I have never seen a company in ph3 cancer trial, with good success probability, trading at such huge discount. Is there anything I am missing here?
'In the in vivo study with PDAC PDX models, combination of BP1003 and gemcitabine caused tumor regression during the 28-day drug treatment period. This anti-cancer activity was maintained for another 21 days, even when drug treatment had ceased'.
The abstract does not tell us how deep the tumor regressions were and in which percantage of the tested mice and if there was any survival improvement versus placebo. I guess it will all depend on the results they will report. $50M market cap for an effective platform to treat all types of cancer is peanuts. Regardless of the short term moves (PPS may go down tomorrow or up , depending on how MM decides to manipulate it, I do not know), this is going much much higher if the technology proves promising in treating all types of cancer as done so far.
The big difference is that this technology allows to deliver more of any drugs due to the fact that directly targets the cancer cells DNA, without affecting the other good cells, hence avoiding all the side effects of normal systemic exposure. This allows to increase enourmously the drug load on target and makes some of the usually non targettable pathways now targettable, in addition to increasing the efficiency of other drugs which target normal targets. In short this could either turn out to be a complete failure or become the investment of the century, and in that case the company could be worth 1,000+ times more than what is worth now.