If this gives them the cash to conduct more trials faster, I'm all for it
Is there such a thing as a "Phase II Approval Trial"? How many Ph2 trials enroll 300 patients?
They need to get that PH3 trial for 011 started. PH2 ended almost a year ago. The clock is ticking. Patients are dying. Competitors are catching up. My guess is we will learn about it from a press release, rather than an off-handed comment at BioFEST, but who knows.
I think investors are starting to realize they probably want to be long CLDX when it announces the start of the PH3 trial for 011 for triple-negative breast cancer. The company has previously said it intends to begin enrolling by the end of 2013.
A little additional patience will be required. No worries. Just hope we get the announcement of CDX-011 Phase 3 trial enrollment sooner rather than later.
The thing I saw that stood out was toward the end of the slide deck. CLDX expects interim results from the ActIV (Phase 3 trial for Rindo) a little over a year from now. That means we wait probably 20-24 months for CDX-110 to get FDA approval and go on sale. That's 8-12 months longer than I had hoped for. And that raises questions about cash burn rate, the potential for dilution to fund the CDX-011 Phase 3 trial and other research.
Will we get a "mystery catalyst" tomorrow? The CLDX execs knew what today's data was going to be. They knew, or had a good idea, of what the doctor was going to say at the presentation. So... why schedule a conference call? No need to amplify what was presented today. Which means (I think) we are going to hear something totally new, probably business-related rather than science-related. GLTA
I would respond to Boston, but it would bump his absurd post back to the top. So I'll do it here. CLDX doesn't need to initiate a PH3 study of CDX-110, it is already in the middle of one. Today's data pretty much confirm that the PH3 result will be positive. The Harvard doctor running the trial, who is not a CLDX employee and has no dog in the fight, said patient outcomes were "exceeding expectations." That's not management spin. Today's news assures CDX-110 approval, when, not if. Once the primary endpoint is reached, 4-6 months for data compilation and NDA submission, followed by 4-6 months for FDA review and approval. That provides a very solid platform on which to begin enrolling a PH3 trial for CDX-011 for triple-negative breast cancer, hopefully now. GLTA
I spent 20 minutes looking into it after the Seeking Alpha article came out. My conclusion was that it would be a fantastic stock - to SHORT.
Possible? I consider it likely. If Rindo gets through its PH3 trial in the next few months, it could get FDA approval in very late 2014. All you need then is for two out of four (011, 1127, 1135, or 1401) to show more promise in trials, and I think we could hit $129 in Jan 2015. That's Four Bags+ from here, 14 months from now. It will be tempting to sell at $69, or $89, but I have a long horizon, I can be patient as long as the trials are going well. GLTA
Imagine a company that has three FDA-approved drugs on the market, two it shares with its partner, Bayer, the third wholly owned. Those drugs were on track to sell around $625 million in August 2013 when the company was bought by AMGN, for $10.4 billion.
The company I just asked you to imagine was real. It was called Onyx.
Now imagine a company that has two FDA-approved drugs on the market, both for fairly rare diseases. Those two drugs had $1.2 billion in sales in the most recent year. One of the drugs is being tested for other indications, and probably has larger potential. This company’s shares sell for $116, it has a P/E of 64, and a market cap of $22.8 billion.
The company I just asked you to imagine is also real. It’s called Alexion.
Now imagine a company that has two wholly-owned, FDA-approved drugs on market, one for glioblastoma forme, the second for triple-negative breast cancer. Those two drugs are expected to do about $1 billion in sales next year. It also has three more drugs in late-stage trials, one for a rare kidney condition, another for non-Hodgkins lymphoma, metastatic melanoma, renal cell carcinoma, and has possible application against Alzheimers. This company isn’t as far along yet as Alexion in manufacturing and sales, but its potential is arguably much greater. Its market cap is $14 billion, and its shares sell for $168.
The company I just asked you to imagine is also real. It’s Celldex, 16 months from now. GLTA
The more I looked into it the other day, the more I thought the way to make money off of NWBO is to SHORT it. GLTA
I would rather see a deal for Rindo that would provide CLDX the resources to put 1127 through mutliples trials for multiple indications, and keep 100% of the IP for 1127. GLTA
Dead on - both the presentation Sunday and the conference call Monday will contain "discovery learning" - and there is every reason to believe it will be at least mildly positive. I am hoping the conference call will provide some insight as to how close the Rindo PH3 study is to conclusion / tentative timeline for NDA submission. But that may be too much to hope for at this point. Here's wishing the patients longer, healthier lives from this vicious and lethal disease. GLTA
Final thought - NWBO's therapy sounds a lot like Dendreon's Provenge drug for prostate cancer. You take tissue from the patient, transport it to your facility, use it as the basis for your therapy, and then take it back to the patient and give it to him. A notoriously complicated and expensive process that Dendreon has yet to make work profitably, years after it got FDA approval. Yeah, as the kids say nowdays, good luck with that!