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AEZS
For every indication the drug will have different price and color.
I have no clue about the reason of the price movement.
It is definitely not the completion of the deal, that had been announced long time ago. Future revenue stream was sold off for fair present value.
AEZS is of course ridiculously undervalued. The company
has an about $40 million /year revenue stream for
royalty and manufacturing for cetrotide.
A little bit more cash.
If they shut down all development and turned into a virtual company that should result in largely higher share price.
Which is to say that the market valuation of the very deep pipleline is very negative.
This pipeline inculdes one drug in phase III, two drugs about to enter in phase III under development by partners (SPPI and KERX)
with no cost for the development from AEZS but reserved ROW rights plus some royalty and milestone in the deal plus many earlier stage promising drugs.
Of course there are many other insanely priced companies.
So that does not explain the current market movement.
Speculation about recent price action
I do not know wat comes next. My impression is that the current price action has little to do with fundemantals of the company, and everything to do with the general market conditions, i.e.
liquidity and insolvency crisis.
The action here is not the same as it was with JaV ro my favorite AEZS. In those stocks some funds with liquidity problems had to unload very fast at whatever price the stock. Both of them somewhat recovered since JAV more AEZS is still at essentailly less than cash + or fast cashable assets.
With RPRX I think the selling was moderate some funds sold some to improve cash positions without panic. Other funds that are interested had stopped buying to preserve cahs positions and perhaps speculating that some of the bigger holder funds are in trouble and they might change over to JAV and AEZs style liquidation.
It is also possible that we had sizeable selling because fuds found very interesting sepecial situations elsewhere.
When NASDA drops about 2.5% much craier things happen, than RPRX dropping 9+ %.
OT: Solvay had the right for fiboiids only. The main indication
for cetrorelix and ozarelix are against BPH. I do not believe they compete against Repros in that indication.
OT: My impression is that the same thing is happening with AEZS.
The company sells for less than its cash + current value of fixed royalty stream of one of its approved medication.
Rics pipeline, royalty from other drug, etc. is not free but negative at this time.
zYeap I sold RRRX and some others bought AEZS today.
Apologies for the obvious pump.
Can you direct me to FAQ like posts about JAV?
I assume that there is no FAQ.
Thanks,
Dunno
You have an absolute guarantee that everything is alright.
This happens usually after I am out. And I am out.
Mike,
I sympathize your feeling, I also would think that given that the statistical analysis plan is prespecified before the trials start,
the analysis of the data should take couple seconds.
For some reasons for every biotech trial it takes couple month,
and cost quite a bit.
Do not ask me why, but if anybody can explain I am curious myself.
You are accusing the insiders of premeditating transactions based on insider informations?
Yes. Document date is February 20. Irrelevant.
Urche,
Thank you for your reply.
As the impressive Claritin sales (See Randy's post #1453)show generic alternatives do not kill the product. And the generic claritin's have same dosage, same indication, etc., they are located next to the branded drug. The only thing missing from them is the name "claritin".
In Prehistin marketing challenge will be of course to get people the stuff before they suffer. Immediate gratification is always easier. But that is why it will need marketing.
(Of course assuming success of the result. But if the trials failed by tomorrow all of us become idiots anyway wether we have caveats in the posts or not.)
Dunno
Another stupid question:
what is the difference, if any between prehistin and other sublingual B12 pills?
Thanks, Dunno.
Aiming,
I have not looked into the documents.
But based on what I read here it seems that Cornell has interest
to push down the price only if they can push well below $1.
If the trials are successful and approval is imminent, there is no way they can limit the price at that level.
There will be more buyers for that price than the number all available shares, including naked shorts.
This seems to me a non-issue unless I misunderstand something.
Dunno
Von E's biggest risk is not any article in the New York Times, but a recurrence of his prostate cancer.
Is it possible that just some random increased buying triggered as a psychological reaction all the other buys, and there is nothing behind this.
In fact it might just be possible that the statistiians working on the data somehow lost it, and try to look for the data or somethin like that?
Oncolytics Biotech Inc. Proceeds to Initiate U.S. Phase II Sarcoma Clinical Trial
Wednesday April 11, 7:00 am ET
CALGARY, April 11 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that subsequent to the regulatory review period for this submission, it is proceeding with a Phase II trial to evaluate the intravenous administration of REOLYSIN® in patients with various sarcomas that have metastasized to the lung. The Principal Investigators are Dr. Glenn S. Kroog of the Montefiore Medical Center/Albert Einstein College of Medicine in the Bronx, New York, Dr. Laurence H. Baker of the University of Michigan Comprehensive Cancer Center in Ann Arbor, and Dr. Monica Mita of the Cancer Therapy and Research Center, Institute for Drug Development in San Antonio, Texas.
"This multi-centre, Phase II trial follows the successful completion of systemic administration trials with REOLYSIN® in the U.K. and the U.S.," said Dr. Karl Mettinger, Chief Medical Officer of Oncolytics. "This trial is the second in a series of Phase II trials the Company has planned for this year, and represents yet another step forward in the Company's clinical development strategy for REOLYSIN®. We are excited to expand our clinical program to specifically include patients with sarcomas."
The trial (REO 014) is a Phase II, open-label, single agent study whose primary objective is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity of intravenous, multiple dose REOLYSIN® in patients with bone and soft tissue sarcomas metastatic to the lung. REOLYSIN® will be given intravenously to patients at a dose of 3x1010 TCID50 for five consecutive days. Patients may receive additional five-day cycles of therapy every four weeks for a maximum of eight cycles. Up to 52 patients will be enrolled in the study.
Eligible patients must have a bone or soft tissue sarcoma metastatic to the lung deemed by their physician to be unresponsive to, or untreatable by standard therapies. These include patients with osteosarcoma, Ewing sarcoma family tumours, malignant fibrous histiocytoma, synovial sarcoma, fibrosarcoma and leiomyosarcoma.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of Phase I and Phase II human trials using REOLYSIN®, its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy. For further information about Oncolytics, please visit www.oncolyticsbiotech.com
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company's expectations related to the U.S. Phase II sarcoma clinical trial and the Company's belief as to the potential of REOLYSIN® as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the tolerability of REOLYSIN® outside a controlled test, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals and uncertainties related to the regulatory process. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.
Source: Oncolytics Biotech Inc.
Do not expect the litigation of the century.
If the trials fail. Nio vale will be left for either us or for Gryphon. If the trials succeed both parties will have strong incentives to settle without litigations.
Impact of the stock price will me insignificant in that case as well.
In sum: it is interesting, but this is not the important issue for us.
PTIE: Remoxy is worthless, but the CEO is worth every penny for licencing from Durect the likely worthless technology for $1 million+ and then shortly reselling provably worthless applications to King for $150 million ++. (he kept a potentially interesting application to PTIE.)
He is also the best applicator of Zebra law.
He started 3 drugs on Phase III. Two without phase II, and one with a marginal phase II.
His remarkable achievements include a PR claiming great success of a pivotal phase III trial, that failed even according to the data included in the PR. Of course the most important data would appear only in conference. (Do not hold your breadth.) The PR was so successful that Wall Street kind of bought it.
From the $150 million he even returns $20 million to shareholders in the form of stock repurchase. What else could you possibly want?
Does Cobailis have patent on sublingual B12 with viagra combo?
The facts remain that
Medicure started enrollment in its its trial couple weeks before they received the SPA with the blessing of the FDA. (The FDA also calls it an SPA.)
I have not seen the law. The quoted text calls itself
nonbinding guideline.
SPA from the FDA.
The quote and the referred document seems to be nonbinding guidelines, and not a law.
But it is indeed ambigouos.
So what is the law?
Telephone call to Medicure ir confirms that the first patient was enrolled in November before the SPA agreement.
They claim that according to the law you cannot start an SPA negotiation after the patient is enrolled. But you can complete the SPA agreement after the enrollment started.
So what is the text of the law?
>FDA regulations specifically prohibit this, so I find that odd.<
Here are the relevant press releases:
http://biz.yahoo.com/iw/061117/0185983.html
http://biz.yahoo.com/iw/061212/0193923.html
Shortly before the initiation the CEO stated in an investor conference that they were ready to start and the only thing they were waiting was the the SPA.
After initiation phone call to investment relation said on the phone that they would be an SPA. As I found this rather puzzling I also called the CFO, who said that they were still hoping to get an SPA, and they would never have started the trial, if they had not been 100% sure that the FDA is satisfied with the protocol.
Dunno
Medicure apparently received SPA for MC-1 about one month after the trial started. FWIW
For now the effect is that the ask price is dropping.
Now it is 95 cent. Is it good news or bad news?
Iwfal: But OTOH Lipitor looks like it may work as well as MC-1 or better.
Could you elaborate?
"dropping CK readings from 100 to 90 ng/mL isn't going to wake any of the sleeping attendees at the seminar."
Obviously true. I mean the part about waking up the attendees.
Fid's statement itself in the tradition of YMB' s worth bashers is a total mischaracterization of the results.
You mean a 2004 article is more important for drug approval than a 2006 SPA? I do not understand that.
Can you clarify?
Iwfal,
Thanks for the answer.
My question was why was the huge difference between previous pahse III and the pivotal phase III? and your answer is that it would be nice to understand.
Does anybody understand?
And in general, why does this happen often?
----------
The pivotal alexion trial failed.
In the primary endpoint they had 0.069. I would not characterize that as bombed.
Had they had a larger n (e.g. 3000 like MCU's current trial) with similar outcome, or primary endpoint (like MCU's again)
their drug would be on market already.
Instead they scrapped it altogether. My bet is that they did not feel they were competitive against MC-1 at that point. Any other guess?
Incidentally for MCU according to the claim inclusion exclusion criteria is the same. Principal investigators are the same.
Most old sites repeat, and virtually all that contributed many subjects. I assume that these sites will provide a very substantial subset of patients. Of course there will be lot more new sites, as the site number is much larger in this trial.
Of course we do not know everything.
---
Alexion results were encouraging and failed in the pivotal trials
Why did it happened? These were large double blind trials with low p values. Why is that (and that is not only Alexion) that you frequently have great double blind phase II and phase II results followed by a bomb in the pivotal trial?
Anybody has any good explanation?
I have no clue what is the most appropriate endpoint.
But if the FDA accepted it for an SPA, why should I have problem with it?
MC-1, stroke, Iwfal:
The company specifically stated that stroke was not part of the SPA. You are right that the data are not convincing. I would think it raises a red flag, and the FDA would have wanted some non inferiority in the result at least.
Do you have any explanation why stroke is not part of the SPA at all? The sample size in all arms will be 5 times bigger, so a somewhat more meaningful data should result.
PGS:
Are you saying that the barious Phase II success reports with MC-1 are not reliable?
BTW, if you find your post about your YMI's phase II critic I would apprieciate.
I do not want to analyze my vague recllection about it.
Regards,
Dunno
The issue is not that MC-1 is cheap. Manufacturing prices have little relation to sales price for patent protected drug.
More intresting that P-5-P is freely available as nutritional supplement. Medicure claims that hospitals will not play with unreliable nutritional supplements, they will buy the drug from.
(I buy the argument.)
Niacin and fish oil can also be bought both as drug and nutritional supplement obviously the drug is much more expensive. KOSP with its niacin was sold for $3+ billion. The fish oil drug is successful in Europe.
Assuming success this will unquesionably limit the price they cna charge but it would be still an excellent business.
> In drug development, you generally get what you pay for.
Looking forward Daichi paid $15 million cash (+ milestone and profit sharing), supposedly after doind due diligence for several years going through everything. (And there are a lot of things to look, as at this point several thousand patients were treated with Nimo.) If we extrapolate this $15 million downpayment to the total value for the USA it is very difficult to say that the value of the company should not be very close to at least the market close for the day.
>In drug development, you generally get what you pay for.
You are much more knowledgeable than me about that, I can think of some examples when this was not true.
But the real question here: Do you claim that the first Tesm phase III's survival advantage was false?
>The CEO pumped the program shamelessly, even going so far as to say it was virtually a lock to succeed.
When?
>He obfuscated about the trial deign, telling investors on multiple occasions that there was no p-value penalty for multiple data looks. (In fact, the p-value penalties were implicit in the sequential-analysis trial design.)
Of course there is a penalty for the chance of early success.
just like there is a bonus for the chance of early failure.
And the two balances each other, and it is a perfectly fair statement to make that there is no p-value combined.
Or you are suggesting that the company agreed "for free" with a chance of premature failure chance while taking penaly for the chance of multiple success. Now that would be dumb.
In short there is p-penalty when you have multiple chance of success, if it is combined with multiple chance of failure, you can avoid the p-penalty.
When they made the Eximias deal they said the financial and personal resources of Eximias merged with YMI's pipeline. Your characterization is simply inaccurate.
----
I am not crazy about Aeroleaf, and I agree that there is distortion. It is likely a superior product to Actiq though.
>I do not understand why you are harping on a relatively minor point when there were big bright red flags about the Tesmilifene program all over the place.
Understanding the moral of the company is important looking forward.
I am also completely convinced that the management believed that Tesmilifene worked. The minor issues are important because they simply contradict to your statement.
What were the big bright red flags again?
Dew,
I think you refer to the Eximias deal.
Which was again last Spring.
For the purpoee of explaining their personal and business spending after the financing which was done previously is irrelevant.
My point was again is that last Fall the CEO made a sizeable open market purchase. Same time the company spent heavily on understanding how Tesm attacks multi -drug resistant/cancer stem cells, and they claimed to be in the process of filing patents about them.
Can you explain the reason for that?
The money raised previously does not explain that.
And they were not in the process of raising money during the time between these and the announcement of outcome.
My point is that the CEO purchase and the Tesm lab + patent work all happened since last Fall. The total money raised after the last Spring related to Tesm is 0. Even The Daichi downpayment for the Japanese Nimo right was in the Summer.
There was no attempt to raise money between last Fall and the announcement of the results.
What they raised previously is irrelevant.
The company was founded to commercialize Cuban invented drugs, primarily Nimo. I do not believe that getting Cuban drugs rights was an efficient market.