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I disagree. Management laid out their plan for the commercial launch of Dsuvia right after FDA approval. They are on schedule and in many cases ahead of the commercial launch outline they set forth during the investor day they held last December. Anyone doubting ACRX management team’s desire to create long term shareholder value has not followed the company for very long.
https://finance.yahoo.com/amphtml/news/acelrx-pharmaceuticals-inc-acrx-q2-012402390.html
Thanks. I very much appreciate it.
I think Dsuvia sales are going to be amazing. My predictions on where I think this stock could go in the next few years based on Global Dsuvia sales are below (my table doesn’t paste very well).
The next few months will be very exciting!
Sales ($M) 800 1,000 1,500 2,000
Net Profits 240 300 450 600
(30%)
Outstanding 75 75 75 75
Shares (in M)
EPS $3.2 $4 $6 $8
P/E 20 $64 $80 $120 $160
P/E 30 $96 $120 $180 $240
P/S 5 $53 $67 $100 $133
Great find! I have been a long term shareholder since 2015, and buying heavily the past few months. I have watched the webcast from the Dec. Analysts and Investors day multiple times. I agree with you, I think Dsuvia has so much potential in acute pain management settings.
Can you provide the link for where you found the transcript for this?
Thanks,
Mike
$12 premarket trade. Is that real?
Athersys and Nikon CeLL Innovation to Collaborate on MultiStem® Commercial Manufacturing in Japan
Wrong and wrong.
The 300 patient phase 2b trial is actually a combo with Herceptin, with 242 patients recently reviewed by the IDMC and SO FAR deemed to not be futile.
You said,
"The 300 person study you linked is a desperate hail mary to salvage what was left of PRESENT and has virtually no chance of success since it is testing HER2 1/2 patients."
So you must also believe that breast cancer patients with their tumors classified as Her2 negative have recurrence of only Her 2 negative cancer?
And you must deny that Her2 over-expression is inversely correlated MHCI expression, whereby increased Her2 down regulates MHCI and HLA leading to poor NeuVax binding. And you deny that Herceptin blocks this signaling and leads to increased HLA expression and more effective NeuVax binding.
You have lost all credibility, and not worth my time.
You have a big mouth for someone without the facts!
2 questions for you;
What does estimated enrollment mean?
https://clinicaltrials.gov/ct2/show/NCT01570036?term=neuvax&rank=2
How many phase 2 trials received marketing authorization from said trials?
You are assuming a phase 3 trial is required for approval. The 300 patient phase 2b trial with Herceptin, SO FAR must be demonstrating some signal of efficacy otherwise the IDMC would have not used the phrase "deemed not to be futile". If the combo demonstrates significant reduction in recurrences - it is possible given all the safety data for these two drugs that we could see a recommendation for marketing approval based on the phase 2b data. But then again, in Biotech investing common sense is not very common. Meaning what I see as black and white based on my common sense, often turns out to be black and blue. It is the nature of the beast.
By my calculations, NeuVax is demonstrating a recurrence rate of less than or equal to 7% and an improvement in DFS of approximately 70%.
This is astonishing to me and I think we will see GALE trading in the not so distant future at a Market Cap of at least 5X expected peak annual sales (> 12.5B).
Biden asked for a moonshot for cancer. Well, the NeuVax shuttle has landed. We are just waiting on the FDA to open the door!
The big questions for me is, how often does the biostatistician assigned to the NeuVax IDMC review the recurrence rates? How quickly does the IDMC meet after crossing 70 events? How is the company notified and what time frame do they have to report the event?
Here's my estimates if 70 events were to occur on the dates listed below.
1/1/2016, NeuVax RR of 7.7%, 61.5% improvement in DFS.
2/1/2016, NeuVax RR of 6.7%, 66.4% improvement in DFS.
3/1/2016, NeuVax RR of 6.0%, 70% improvement in DFS.
I wouldn't be hoping for a merger or acquisition! Why sell the whole farm when you can rent out the woodshed.
I would much prefer a licensed agreement for NeuVax, which would include shared profit and losses outside of the US only, a large upfront, and a minimum 10% equity investment in GALE. In addition, the deal would not include rights to new indications for NeuVax but the company would have first rights of refusal.
U want to destroy shorts this agreement certainly would.
If that is true, my model suggests about 50 recurrences in the Control group and around 20 in the NeuVax group in December, equating to approximately a 60% improvement in DFS for NeuVax treated patients. How important is this? Assume an annual WW patient population of 100,000 for these BC patients and a 60% improvement with NeuVax would translate into 12,000 saved lives per year!
Yep. Long time shareholder just waiting for the age of miRNAs to come! For fun go to PubMed at the NCBI web site and search microRNA. Pretty amazing how far they have come.
Tom,
Sorry for the late reply. Yes, quite exciting times. September is here and I am convinced we crossed through at least the 30% improvement in DFS. The one wild card is the exact number of enrolled patients in each group 20 months ago. I think my model is fairly close to the real numbers, but no way to know for sure. If these numbers are accurate and historical recurrence rates are holding for this patient population then we will be celebrating soon! I updated the model (same numbers, calcs, etc) to a more visual graph on my Twitter account.
IDMC PR was telling. No CardioTox issues and no deviations was big. This meeting was in June, so I'm assuming if called for futility it would have happen in this meeting of they had up to date trial numbers.
Mitt's presentation was amazing. The bolded ER/PR- NeuVax phase II patients vs. Control patients is striking. This pop has a much higher recurrence rate regardless of Her2+ status. I have the paper if you need it. 1/30 recurrences for patients with above median E-75 positive T's. Wow what an efficacy Biomarker. The slides on vaccine efficacy depending on disease state. Mitt's tone change for immunotherapy in BC. Hope we get a readout on the combo low Her2 trial soon. I could go on but this is a game changer and I'm proud my investment dollars help fund it!!
I agree! By my calculations NeuVax has crossed 30% DFS and will likely cross 50% DFS in Septemberish. I think we will see funds accumulating more and more as we get closer to EOY. Baker and Sabby have already started. Anyone betting against NeuVax right now is insane. If we go past the EOY without the interim analysis NeuVax will be approaching >%60 DFS which would huge for this patient population.
In addition, the preliminary results for GALE301 were amazing. If the final results of the phase 2 demonstrate the same efficacy, this will be incredible for patients and shareholders.
Our reward is coming very soon! Be patient.
The difficulty in estimating when 70 events will occur for the PRESENT trial is in what info is available to us in regards to actual enrollment numbers over time since the start of the study. The only information I can confirm are the following; 535 enrolled September 2014 and 758 enrolled April 2015. Given this I built the model making my own assumptions on how many patients were enrolled for each group each month since the start of the study. A key metric to the accuracy (or lack thereof) of my model is my assumption that at least 400 patients were enrolled on or before 1/1/2014. If this is the case and NeuVax is demonstrating a DFS less than 30% then 70 events should have occurred already. A 50-75% DFS for the NeuVax group would put 70 events between 09/2015 and 04/2016.
Disclaimer: this model is nothing more than my estimates and depends on a lot of unknowns including % of each group enrolled when, historical recurrence rates being maintained, drop-out rates, etc.
Yep. Still holding strong. Hoping we get through June without reporting of the interim results for NeuVax.
All in! Been a long time GALE shareholder since 2010 and haven't sold a share. I've made good money in Biotech and I'm convinced GALE will be the next PCYC.
IMO, those who have sold out or haven't covered their short position may experience some regret over the next few months. I think the share price will slowly but steadily climb into May-June time frame when I project NeuVax will cross the 30% DFS mark. Every day after that time frame that the interim analysis isn't reported just adds to the % DFS and should add to the share price. I'm certainly not sitting on the sidelines and losing out on this opportunity. Fortunately for me I am a hardcore scientist by training, however I can see how many can be deceived to drink the unscientific Feuerstein Koolaid!
Mayo clinic hypes a breakthrough vaccine for triple neg breast cancers. Can't get much info out of the article but it does point out 2 things; they certainly believe in the NeuVax technology and approach for preventing BC and notice the target of their new vaccine (FBPa) = GALE 301.
http://www.usatoday.com/story/news/nation/2015/02/03/mayo-clinic-triple-negative-breast-cancer-drug-trial/22785941/
From my understanding the way the trial is set up, the interim analysis will only be looking at safety and futility. Which means the only public statement released will be to continue the trial or stop the trial due to safety and/or futility. This does not mean the data for efficacy isn't reviewed, it is!
However, I'm hoping the data at the interim analysis is overwhelming enough that regulators consider it unethical to prevent this set of BC patients from receiving NeuVax.
I should have also pointed out that of the 157 clinical sites registered for the trial only Ukraine has a large number of withdrawn sites. You can find the site info below.
https://www.clinicaltrials.gov/ct2/show/study/NCT01479244?show_locs=Y%23locn
I'm not sure it is fact that there was/is a high drop out rate for patients in Ukraine. What we know for sure is about half of the Ukraine clinical sites have withdrawn from the trial. There is a big difference between drop outs and a site withdrawn. There are essentially no side effects with NeuVax other than the local immune reaction at the site of dosing, so I have trouble believing drop outs are high. My models have been updated a few times since last fall more so to reflect a slightly slower enrollment pace. Which has more to do with the requirements for a patient to be eligible for entry into the trial versus not enough clinical sites, available patients or drop out rates.
NeuVax PRESENT Phase 3 Trial Predictions. My estimates for NeuVax DFS I put on Twitter. My prediction, if we make to May without interim results (70 events) reported, NeuVax will be approved!
https://twitter.com/vfa_scf/status/553647467493728257
NeuVax Phase 3 Trial. By my estimates, over 670 have enrolled and 38-40 control patients have had their Cancer recur. Since the interim results (70 recurrence events) have not been released yet, it means NeuVax is at least demonstrating a 25% reduction in recurrence. We only need a 30% improvement in DFS for approval.
Every week from here on out that the interim results are not released increased the DFS for NeuVax patients!
I'm certainly looking forward to 2015.
This finding could expand the market for NeuVax. It also demonstrates political science journalists like Adam Feuerstein are clueless when it comes to understanding Her2 expression and how it relates to breast cancer.
Biocept's Patented Platform Identifies Clinically HER2-Negative Patients With HER2-Positive Circulating Tumor Cells
http://finance.yahoo.com/news/biocepts-patented-platform-identifies-clinically-133000572.html
That sounds about right to me! Sad that it is most likely true.
Adam Feuerstein doesn't like me!
I have been putting a few messages on twitter like the ones below and now Adam Feuerstein has blocked me from reading or viewing his twitter site. I count it a big compliment!!!
Anonymous poll: Only 1 in 10 scientists believe political science majors are qualified to cover biotech science @adamfeuerstein $GALE
Anonymous poll: 9 out of 10 short hedge funds prefer political science journalists to manipulate biotech stocks | @adamfeuerstein $GALE
How did the $GALE poster get accepted, using the scientific term "Intermediate" for HER2 2+ vs the AF political science term "Middling"
Too funny! TheStreet.com accused The Post of concealing facts and making false claims | $GALE
That is possible if NeuVax generates efficacy of around 75% reduction in recurrences.
NeuVax Phase 3 trial entering key moments. If interim results are reported (70 events) in Nov. - Dec. NeuVax < 20% reduction in DFS, after March NeuVax > 30% reduction in DFS.
Bashers don't have much longer to bash!
I expect a run-up will start in Jan. or Feb. if interim data has not been announced by then.
Small study but promising results so far. Would like to see analysis of ovarian vs. endo cancer, to assess if one patient pop benefitted over the other.
Great data presented by RGLS. Stock up >100% and ROSG is down. miR's certainly have a promising future!
Regulus Therapeutics announced that it has demonstrated human proof-of-concept with a microRNA therapeutic from an ongoing clinical study evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting microRNA-122, for the treatment of hepatitis C virus infection
Wash Post article on Adam Feuerstein and how shorts and scum ban journalists destroy innovation and small biotech companies.
http://www.washingtonpost.com/business/northwest-biotherapeutics-stock-woes-highlight-the-harm-of-short-sales/2014/09/26/78b99b0a-4507-11e4-b47c-f5889e061e5f_story.html
With these new enrollment numbers, 70 events needed for the interim analysis now estimated to occur between 5/1/2015 [10% NeuVax recurrence] and 12/1/2015 [5% NeuVax recurrence rate]
I personally believe if NeuVax yields a 50% reduction in DFS or better at the interim analysis it would be hard for the FDA to not grant early access with NeuVax's superior safety profile! Posted this on Yahoo - don't think there's a long left on that board!
PBYI up $20 today to $269. One drug in pipeline with much less market potential compared to NeuVax! Go figure!
The phase 2 data on NeuVax is very convincing! My models estimate full enrollment will happen around October and possible interim results March 2015. The NeuVax/Herceptin data is also impressive and if the combo also works in Her2 3+ then NeuVax would have a large market opp.
It really comes down to who you believe. The data and Dr. Mittendorf or lying scum political science major AF.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3428069/pdf/nihms385833.pdf
Roche just bought Intermune for $8.3B. Basically a one drug company. PBYI another one drug company has a market cap > $7B.
Gale Pipeline
Abstral
Zuplenz
NeuVax (Her2 1/2+)
NeuVax/Herceptin (Her2 1/2+)
NeuVax/Herceptin (Her2 1/2/3+)
GALE 301
GALE 401
Am I missing something here?
Can't wait for the day they get Feuerstein.
July 29, 2014
Washington, D.C. — Citizens for Responsibility and Ethics in Washington (CREW) today requested the Securities and Exchange Commission (SEC) investigate possible illegal manipulation of stock prices in Northwest Biotherapeutics, a biotechnology company developing cancer treatment drugs. Strategically released blog posts by well-known biotech stock analyst and senior columnist for TheStreet.com Adam Feuerstein seem designed to cause the price of the company’s stock to fall at times when short sellers were financially overexposed. CREW has asked the SEC and the U.S. Attorney for the Southern District of New York to conduct a full investigation of the timing of Mr. Feuerstein’s posts and their relationship to short seller financial interests.
http://www.citizensforethics.org/legal-filings/entry/crew-sec-investigation-manipulation-drug-company-biotech-stock-feuerstein