John H. Ford

Deep value, special situations
John H. Ford
Deep value, special situations
Contributor since: 2011
Below is the link for the verdict form that the jury filled out. This is must reading for all VirnetX investors.

http://bit.ly/1QGREXM

VirnetX's legal team did an outstanding job.
What's important in the jury decision besides the large damages number is willfulness because willfulness could produce treble damages. Here's what MarkmanAdvisors had to say:
Markman Advisors LLC ‏@MarkmanAdvisors 1h1 hour ago
Final $VHC verdict numbers- $334,908,773.73 + $290,725,0667.31. $334M for infringement 2009-2013. This could potentially treble to $1.5B !
I'm planning on speaking with the company, and if significant updates are discovered I will post. All investors should read this piece regarding Symantec:
http://bit.ly/1ZxIije
You are correct, entering and exiting profitable trades on a consistent basis is very challenging. In my experience, few are able to accomplish this. It's a full-time job sometimes involving 16 hour days, 7 days a week.
Fortunately for us, markets are irrational, and extreme mispricing exists.
My trading strategy focuses on catalyst driven short-term trades. When the shareprice goes from $.29 to $.75 within 9 days, that’s a successful trade.
For a complete overview of all trades, the following link should be helpful:
http://seekingalpha.co...
hlharvey
Thanks for pointing that out. I have added the other HERE link that takes you to the rest of the analyses.
I agree with your assessment of the meeting. Telesta should've had one of their big guns running the meeting, and that wasn't the case.
I spent the last 3 days reading and researching 175 pages of briefing documents, and listening to yesterday’s advisory committee meeting, and given all the information, I was surprised at the outcome. The entire vote was based on this question:
Does MCNA have an overall favorable benefit risk profile for the treatment of non-muscle invasive bladder cancer at high risk of recurrence or progression in adult patients who failed prior BCG immunotherapy, e.g. in patients who are BCG refractory or BCG relapsing?
According to the FDA analysis, the primary endpoint of DFS 1y was 20.9%. The safety profile was stellar. With that data in mind the obvious answer to the above question is yes. But the advisory committee voted no primarily because panelists questions about the trial and data were not adequately answered.
Many of the doctors who voted no made it clear that they almost voted yes, but didn’t quite feel comfortable with the presented information.
What’s encouraging is that of the urologists on the panel, the majority voted yes. This is a needed drug that urologists want. There was only one patient on the panel, and he voted yes also. If the panel would have contained only urologists and patients, I believe the overall vote would have been yes.
I am disappointed in the outcome, because if the FDA does not approve in February, patients will have to wait for another trial to be conducted before having access to this drug. In my opinion the advisory committee ignored the big picture, and if the benefit risk question would have been answered literally, a unanimous yes would be the only reasonable outcome. From all the data I saw, the benefit outweighs the risk.
The FDA will be basing its decision in February on the following question:
"If the FDA decides that the benefits of a drug outweigh the known risks, the drug will receive approval and can be marketed in the United States."
Since the benefits appear to outweigh the risks, the FDA should approve the drug. However, given the advisory committees negative vote, the drug may not be approved.
It’s interesting that Valstar went through the same issue with the advisory committee. The advisory committee did not recommend approval, and yet the FDA went on to approve Valstar, going against the advisory committee’s recommendation. The objections the advisory committee had to Valstar are almost identical to the objections raised against Telesta’s drug. Here is the summary from the press release:
The Oncologic Drugs Advisory Committee of the US FDA has failed to recommend approval of Anthra's valrubicin (AD 32, VALSTAR) for the treatment of refractory bladder carcinoma in situ. The committee reportedly considered that the open label studies conducted by the company were not rigorous enough and that without a controlled trial it is difficult to assess whether delayed cystectomy will result in an increase in bladder cancer. According to results presented to the FDA by Anthra, valrubicin treatment delayed cystectomy by 8.3 months in nonresponders and 23 months in responders. Anthra had reported that 22% of patients had a complete response, but upon reanalysis of the data, the FDA found only 8% of patients had experienced a complete response. …
I have no idea what the FDA will do in February, I can only hope it will give patients access to MCNA. The FDA is generally reasonable, and understands the level of need.
Here is the link to today's webcast. Just scroll down to the webcast information section.
http://1.usa.gov/1H83LMv
I would like to see a study documenting shareprice movement immediately before advisory committee meetings. That could be interesting.
But what's important for investors is that the briefing documents should be released on Monday, and since these documents will affect the outcome of the meeting, they will be important for all investors to read.
I encourage investors to post relevant information regarding the briefing documents. The information on this forum has been outstanding, and multiple inputs regarding the briefing documents should be helpful.
87.2% at 6 months for Valstar versus 87.3% at one year for MCNA. That comparison should be meaningful to the FDA. I assume Valstar doesn't provide one year data, because efficacy drops, but of course that's just my guess.
Those are impressive numbers, actually life-changing for patients. Does anyone know what the 1, 2 and 3 year PFS rates are for Valstar?
Thanks for pointing me to that panel discussion. Dr. Lerner is one of the leading experts in the bladder cancer field, so his comment stating that we need more drugs for treating bladder cancer is important. It would be great if he is on the FDA advisory committee on November 18. He is definitely a qualified candidate.
All great points. Who said this was a much needed treatment? Was it someone from the FDA, or someone on the panel? Do you have a link to that comment, and what is the actual statement, rather than the paraphrased statement?
There's no way anyone except insiders can know about a near-term Japanese deal, so I don't think that's what's pushing the share price up. However, given the recent Ipsen deal announcement, if Japanese negotiations are going on, Japanese companies would be motivated to get a deal completed before the advisory committee announcement, otherwise the deal could be a lot more expensive. That said, I would be surprised to see a Japanese deal announcement anytime soon, but keep in mind I was surprised by the Ipsen deal.
What makes this trade really interesting is that even with the 100% share price increase we've just seen, we could see a much larger run up following a positive advisory committee announcement.
There's been a lot of good information posted here, thanks to all.
The FDA advisory committee meeting on November 18 will be webcast. Here is the link:
http://1.usa.gov/1H83LMv
The FDA intends to make background material available to the public no later than 2 business days before the meeting. This will definitely be worth taking a look at.
The meeting runs from 9 AM until 5 PM. From 11:15 AM until 12:15 PM, the public is allowed to present arguments. That could be interesting, particularly if families of patients in need of this drug were to speak out.
The Ipsen deal definitely increases Telesta's valuation, especially when you consider that Ipsen should paying for everything, so whatever Telesta receives goes straight to the bottom line. At this point I can't speculate on how much the deal increases Telesta's valuation, but in my opinion this was a very important deal.
DWD and Zac, thanks for posting that, all good points.
The margin information came from the company. Thanks for the link to the patent information, you are correct, very important.
The $400 million number is the company's estimate of peak sales. Another SA author estimated the total addressable market to be in the $1 billion range, and if $400 million is peak sales, that's probably about right.
Thanks for pointing that out. It's been changed.
There was nothing in the trial data that concerned me. Please let us know what the oncologist has to say.
Your concern is justified. The risk is that a 2nd phase 3 trial is required. But keep in mind the first recommendation will come from the advisory committee, so the question becomes whether or not the committee will be less stringent regarding trial size than the FDA. We will see shortly.
I don't have data showing approval versus trial size, but it would be interesting to see.
With regards to placebo, think about this; a placebo would be a death sentence to the participants who received the placebo.
Yes, I agree that is a small trial, but given the efficacy and safety are far superior to a drug they already approved, I am optimistic it provided sufficient data.
This was a very successful offering. Chanticleer will now be fully funded and $60 million in annual revenue and $6 million-$8 million in EBITDA should occur as planned.
Here’s an explanation of the extension: Depending on your broker, if you didn’t place your order 1 to 3 days before the deadline, you could not get filled. That left many investors who wanted to purchase shares unable to, so the extension will accommodate those investors.
At this point Chanticleer doesn’t need any additional funds beyond the $6 million already committed, so in my opinion the extension is Chanticleer’s way of extending loyalty to existing shareholders who wanted to participate in the offering, but didn’t get their orders placed in time.
If the rights offering is 100% subscribed, Chanticleer's valuation will be about $30 million, using current share price levels. A $30 million valuation is way too low for a company that generates $60 million and $8 million-$10 million of positive EBITDA.
The company just reported that two states are now signed up for reimbursement. This is happening much quicker than expected.
You bring up some really good points that I should have addressed in the article. When a popular new restaurant opens, there is something called the honeymoon phase where initial revenue actually exceeds normalized revenue. For that reason my estimates are actually conservative, with regards to new restaurant revenue.
The valuation for each Good Times restaurant is actually higher than $2.4 million, because Good Times valuation has gone up since I made the calculation. To arrive at the valuation per restaurant simply take Good Times valuation of $117 million and divide it by the company’s 37 restaurants, which gives each restaurant a valuation of $3.1 million.
Thanks for the schedule info. What makes you think results of the meeting will be public tomorrow, and not at a later date?
With a Monday meeting, when will the results be reported?