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The market certainly disagrees, up nearly 5X since early last year. So do the new institutional investors, buying in at $5.25 after that run. That would normally cause most folks to reassess their perpetually negative opinion....
Again, until the beef is served (pronounce results and revenues) this is nothing more than watching paint dry.
I imagine there are now well over 1,000,000 shares short.
changes -
Tox is a 6 month process (scheduled to start in Q1 and be reported in Q3).
The plant should be completed next month some time, then about 6 months to commission and produce the 3 test batches (end of summer?). Should dovetail nicely with the timing of tox report.
They have already done much of the ground work for initial trials in Australia and I presume would be doing that now for other location(s) if they opt to go somewhere else first to get the rooms they need. Hopefully wherever they go they are able to do a combined Phase I/IIa, and that will almost certainly be a determining factor on trial site. Certification of the new facility would be required if trials were to be initiated in the U.S.
Efficacy studies I believe can be done very quickly, maybe a couple weeks, so assuming plenty of material can be produced with the scale-up in the existing facility (for both tox and efficacy studies), no problems getting those done while other milestones are being accomplished.
Then filing of the IND's and 30 days before trials can be started. (That timing may vary somewhat in other geographies).
So it is certainly possible to get trials started in Q4, but there are a LOT of irons in the fire and I have generally found it prudent to pad these things a bit. You know, the best laid plans....
Given the potential magnitude of what they are doing, a quarter or 2 difference on the timeline is really immaterial. Except of course the potential impact on Weedie's party planning activities.
Clinical Trials in Q4 2014 means it is as early as nine months away.
Seemingly endless supply through the same MM (EDGX) that has been capping the stock for weeks.
The short interest in the stock is very low.
Based on the overall volume and size of transactions earlier today it looks like accumulation by a fund or someone of size.
Note that the date on the article is 2010.
no room for anybody to complain about the pace. It's a new game...
Under normal conditions the short interest would be expected to steadily grow until it reaches at least 5%, quite possibly higher. Currently at only about 2% of the float.
I'm showing only 8,000 or so traded in the last minute.
The COMBINATION of exceptionally low toxicity with the fact that the drug is HOST INDEPENDENT would put the odds of approval into the 80 to 90% or above range.
If the drug is used on a compassionate basis for H7N9 and gets outstanding results that could lead to an ICPT type move (i.e.: multiples in a day) before CTs are completed.
I think Changes is right, 2015 for the really explosive move. The stock could do well this year however, with a number of potential catalysts, but it is the pending results for Phase IIa that will really get the stock moving. Assuming of course that everything goes well in the interim.
VRUS was taken out by Gilead for $11B for a couple of Hep C drugs that had just completed Phase II. PCYC achieved a market cap of $9B after designation as Breakthrough Therapy and prior to approval of their 2 drugs for MCL and CLL. Their treatment for MCL was the second approval under the new Breakthrough Therapy designation. Still awaiting the approval on the treatment for CLL I believe.
I don't think I could have been any clearer in my last post.
in it's glaring omission of some key parameters. Tools like that are never meant to be used in a vacuum.
The idea that you would take that as gospel, ignoring all controvertible evidence, makes a statement as to the value of your final result.
Obviously, you would have to compare on comparable end markets.
I showed that it is not.
For the third time, I deem your hypothesis on probabilities as essentially worthless. Do an industry comparison of market caps with other preclinical biotechs that haven't inked deals and you should begin to see the light.
In a discussion on NNVC you introduced the notion of 1X sales as if that was within the realm of reason. Glad that you are backing off of that position now as it was really silly.
I know exactly what you are saying and it is based on a flawed hypothesis of what you think the market is telling you but one that you continue to imbibe as gospel. You continue to miss the most glaring metric of what the market thinks of the probability of success.
You stated--
BTW, there is nothing ridiculous about a company selling for 1x sales.
Yes, 1X sales for an emerging drug discovery biotech with a successful drug is absurd and has no basis in fact. Yes, it is fairly easy to ballpark a minimum potential market for Flucide. No, I don't buy your contrived percentages as accurately reflecting odds of success. If you're familiar at all with this industry then you would know that it is not common for a preclinical biotech to sport a market cap in the area of $240M. That, more than any other metric, tells you that odds of success are perceived to be significantly higher than typical. And significantly higher than you are perceiving them.
Completely untrue. Look around, you don't typically see preclinical valuations in this range. Your ultimate valuation on approval is deeply flawed as well. That's an easy one, simply look at the size of the existing market for Tamiflu and Relenza and apply an industry standard P/S. That would be conservative for a drug that is an outright cure and also does not factor in the value of the platform and potential of follow-on drugs. You are saying that with a successful flu drug the stock would sell for about 1X sales which of course is ridiculous. Last, your odds of success do not factor in the uniqueness of the mode of action which makes the successful translation to humans much more likely than your typical preclinical drug candidate.
No, tox has always been expected to be a 6 month process. Latest guidance from the company (LD Micro presentation) is for start of GLP tox in Q1, to be reported out in Q3.
A $244M market cap suggests otherwise.
- This was coincident with a short-term split-adjusted closing SP drop from $1.68 to $1.12 (-33%) in mid/late Feb. 2013 which bounced back to $1.68 by Feb. 28.
if that is your answer then, like I said, you are not very well versed on exchange transitions as they relate to development of short interest.
A well placed finger in another orifice can also constipate one's thinking.
Am I to understand that you think a short interest of 1.3% is a typical number and that you don't believe it would be expected to naturally trend higher after a move to a new exchange? It has to reflect a conspiracy among short sellers?
The market hasn't picked up on anything yet.
The price pre split is still about $1.43 ($5.00 / 3.0).
Part of the rise was certainly due to buying out SeaSide early, but that was only one of a number of significant events taking place in 2013, key among them being orphan status designation for Dengue by both the FDA and EMA and the NDA with PHE to test both H7N9 and MERS, not to mention the significant progress on the new cGMP manufacturing facility and the beginning of tox studies.
As for the short position if you don't believe that the shorts are beginning to mount a campaign then I submit you know nothing about what shorts do.
You are making a lot of arbitrary statements. The stock is up nearly 5X since the lows of last Feb, yet you don't think that represents a significant shift in perceptions?
The short interest in the stock is a measly 1%, yet in your mind the shorts are beginning to mount a campaign?
Being skeptical is good, I'm just not sensing that you are perceiving the tectonic shift that has taken place over the last year. The market has certainly picked up on it.
I don't think you should go outside tomorrow, you might get hit by a meteor.
Don't know Rider but DRACO and Vecoy are probably 5 yrs behind NNVC. Plenty of time to see if the NNVC approach translates effectively to humans and get to market. In any event, the DRACO approach seems inferior since it involves the destruction of infected cells as opposed to eradication in the blood. And Vecoy last I heard had only tested in roaches.
The short might be betting that management can't execute. That's a pretty straight forward reason and is supportable based on the past.
the short interest is minuscule at about 1%.
As soon as an antibiotic is created that can create immunity the virus, it has changed again.
Doing Phase I clinical trials in Australia can save the company a good bit of time because they have an accelerated application process and, additionally, it wouldn't require having to wait for FDA certification of the new cGMP facility prior to starting. (They would also get a 45% rebate on expenses). Once Phase I has been completed it should accelerate the IND approval process with the FDA/EMA, giving them the option to go elsewhere for Phase II. That's probably the most expeditious way to do it.
FDA and EMA will then review. If the filing is early enough, approval to begin clinical trials could come as early as Q4 2014 or Q1 2015.
the majority of the selling volume is still coming through the same MM.