SLA - SILK LASER AUSTRALIA LIMITED

[Spicer69]

QUOTE (maiden @ Wednesday 27/02/08 03:07pm)

There's enough suspension going on in peoples minds/chests ATM without a trading suspension.......and the suspense is killing me....lol..... http://www.sharescene.com/html/emoticons/weirdsmiley.gif

[PJ83]

I'm pretty sure the halt is just so the company can prepare the announcement for the ML. Obviously the RMOH would know the ML has been approved, so would its employees now and all of SLA company - so they have to halt so they can fully prepare an announcement.

 

I will have a sleep in tomorrow till near ten so I won't have to hit refresh on the asx site for too long!!

 

 

[GarryW]

I have just read all of ABS notices today, can they really do what they did yesterday and sell all those shares knowing they are in problems? I would be pissed right off if i had bought. ?Can the ASX reverse these insider trading deals? I know you can get away with murder today but this is over the top http://www.sharescene.com/html/emoticons/sadsmiley02.gif

[kline]

In reply to: GarryW on Wednesday 27/02/08 07:08pm

I don't think this has any relevance to SLA, Garry.I didn't notice any large volumes changing hands lately at SLA.

[Spicer69]

Except for the childrens cold and flue trials it has SFA to do with ABC learning....

[Torchwood]

In reply to: Spicer69 on Wednesday 27/02/08 06:37pm

Ok I here the groans but I thought I would do one more post for the hell of it. The good old moderator doesnÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢t like the Russian script and I thought I wouldnÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢t push the boundaries and post in Hungarian (mm why did I pick that language). Many of you have PMÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢d me over the last 2 or 3 days. I tried to get back to most of you but I now call it quits, I donÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢t spend a lot of time on the computer and I have many other things to do.

 

Best of luck to all who hold. Many of you obviously have significant money in SLA and are true believers. (I donÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢t hold for what it is worth but have been ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“around the edgesÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ for sometime with SLA) A number of you have asked me is it bad news re the trading halt. Bottom line is I have no idea but I am very confident is has nothing to do with my concerns. For what it is worth I think it will be very positive announcement and consistent with what you are saying on this thread. It should be positive to the SP.

 

So what are my concerns. Let me post an article and I will get back to you

 

[Torchwood]

In reply to: Torchwood on Wednesday 27/02/08 07:26pm

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA)

NATIONAL TRADE ESTIMATE REPORT ON FOREIGN TRADE BARRIERS (NTE) 2007

RUSSIA

Trade in the Russian pharmaceutical sector continues to be impeded by

the failure to protect commercially valuable test data, poor enforcement of

intellectual property rights, and non-transparent regulatory procedures in

registration and quality controls. New adverse regulations for pharmaceuticals

were introduced or were under consideration by the Russian parliament and

government bodies in 2006 despite WTO accession negotiations.

Market Access Barriers

Reimbursement Procedures

Reimbursement decisions are not made based on objective and verifiable

criteria. Mechanisms for purchases of reimbursed drugs and tenders are non

transparent. Foreign firms are often discriminated against in tender processes.

Lists for state purchases are drafted with virtually no transparency and little

concern for quality and safety interests. Such criteria are neither contained in the

legislation nor practiced by the authorities. In addition, no appeal procedures for

reimbursement decisions are provided.

The drug listing/delisting process for the new federal drug reimbursement

program instituted in 2005 was highly opaque with little information available in

written form. No criteria were announced. No recourse or independent appeal

procedure was available.Marketing Approval

Significant delays for marketing approval exist in part because the lengthy,

non-transparent local process requires duplicate clinical trials. Arbitrary fees are

discriminatory to foreign companies and are not charged directly by the state

registration body but instead by a third-party not stipulated in the Law on

Medicines. Unnecessary requirements for re-registration (every five years) and

corresponding discriminatory fees for foreign companies are imposed. An

Amendment to the Law on Medicines adopted in first reading by parliament in

July 2005 imposed a requirement for the re-registration of medicines in case

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“other dataÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ submitted during registration changes. This vague terminology

opens room for corruption.

Quality Assurance and Mandatory Certification

Rules regarding state control of medicines are excessive, administered

arbitrarily, and not harmonized with international practice. Control procedures are

carried out in a non-transparent manner: not by the responsible state body but by

various opaque third parties who obtain access to confidential data on preclinical

and clinical trials and impose their fees and terms on applicant companies

unilaterally. Companies have no recourse since if they donÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢t comply they do not

obtain registration or other required certification. Control procedures entail

provision at cost to manufacturer of samples, which are not returned to the

company. The number of samples is set arbitrarily.

Clinical Trials Tax

Medicines imported for clinical trials face a VAT levy of 18% instead of

10% levied on medicines imported for sales. This higher tax rate impinges the

ability of companies to perform obligatory clinical trials, represents a clear barrier

to trade, and may result in a loss of opportunities for Russia to attract a greater

number of clinical trials. The Russian Government failed for the fifth year to issue

a List of Medicines required by the Tax Code that could solve this problem.

Import Regulation

In July 2005, the Russian government issued new rules regarding import

of pharmaceuticals where instead of a widely expected lifting of the import

license it set a new provision allowing a restriction on import of pharmaceuticals

on an unspecified ground by a government decision or an international treaty. No

justification, criteria, procedure or any further details are provided in that decree

with regard to its application. In addition, the Ministry of Health (MOH) indicated it

was contemplating changes to the Law on Medicines that would ban import of

pharmaceuticals by foreign companies.

Import License for Medicines

The current procedure for obtaining a pharmaceutical import license is

duplicative and involves unjustified costs. To obtain a license, according to the

July 2005 decree issued by the Russian Government, an applicant has to go now

through three agencies: i) Narcotic Committee; 2) Roszdravnadzor and 3)

Ministry of Economy (MEDT). Then a license has to be registered with the

Federal Customs Service. Associated fees include: i) a fee collected by a third

party appointed by Roszdravnadzor which is not commensurate with service but

rather is unfairly calculated as a percentage of the contract value, and ii) a fixed

nominal fee collected by the MEDT. The MEDT has often stated their view of this

license as unnecessary, however, a government decree issued in July 2005 has

reinstated the requirement for that license instead of eliminating it. The Decree

also failed to specify a fee or a full timetable for the license issuance.

Intellectual Property Protection

Data Exclusivity

Russia currently does not provide data exclusivity. The current Russian

Law on Medicines does not distinguish between originators and copiers and, in

theory, requires both to provide ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“results of clinical and preclinical testsÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ to gain

marketing approval of their drugs. In practice, generic companies register their

drugs and do so in the absence of any serious clinical or preclinical data through

an arbitrary, discriminatory procedure.

Contrary to TRIPS Article 39.3, this legal regime allows for unfair

commercial use of test data. It fails to ensure that no generic applications,

without the permission of the person who generated and originally submitted the

data, may rely on such test data in support of an application for product approval.

This has left the U.S. research-based pharmaceutical industry vulnerable to

copying by domestic and foreign generic companies prior to the end of a term

when proper data exclusivity would have expired.

Current proposals for changing the Russian Medicines Law would permit

Russian authorities to continue their current practice of accepting - on their face -

the validity of documents provided by Russian generic manufacturers without

looking into the validity of the documents for registration or their claims. Such a

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“positive approachÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ rests on the premise that Russian MOH officials will act in

good faith in implementing the proposed law. However, recent statements and

discriminatory actions by Russian MOH officials that favor local companies over

importing companies in determining access to the newly launched federal

reimbursement program demonstrate that Russian officials are determined to

favor local over imported pharmaceutical products

To be compatible with TRIPS Article 39.3, Russian law needs to be

amended to require non-reliance for a period of at least five years, to prohibit

disclosure of confidential information, and to provide procedural safeguards that

will permit the proper and timely enforcement of the law.

Neither the Russian Law on Medicines, nor the Russian Law on Trade

Secrets, nor the Russian Competition Law contains specific provisions regarding

the non-disclosure of test data on new drugs.

Enforcement Concerns

The current legal system is not equipped to penalize violations of

intellectual property rights and problems remain in the administration and

adjudication of patent disputes and violations of registered patents. Current

penalties for intellectual property rights violations are not adequate to

compensate for the injury the rights holder has suffered from the infringement of

their intellectual property rights.

Trademarks

Trademark infringement has been permitted and sanctioned through the

registration of trademarks very similar to the original trademark. There have

been some positive signs of enforcement in court cases on trademark

infringement, but overall, enforcement remains a problem.

Ban on Use of Pharmaceutical Trademarks in Prescribing

New federal reimbursement rules arbitrarily issued by RussiaÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s

Roszdravnadzor in May 2005 require doctors to only prescribe medicines using

non-proprietary names and not use trademarks. Furthermore, an amendment to

the Law on Medicines was approved by the Russian parliament in July 2005 that

intends to ban the use of pharmaceutical trademarks completely in all

prescribing, as well as in government purchases. President Putin has indicated

his opposition to this legislation.

Counterfeiting

There is weak enforcement against counterfeit medicine producers, three

quarters of which are produced domestically representing 4 to 12% of the

market. Russian law does not specifically criminalize pharmaceutical

counterfeiting and injunction measures are not applied. A definition of a

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“pharmaceutical counterfeitÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ was introduced in the Law on Medicines in August

2004, however, no related prosecution articles have been added in the criminal

and civil legislation. There is no procedure for evidence gathering and

acceptance by courts to facilitate court proceedings in counterfeit cases.

Penalties for trademark infringement are completely inadequate to serve as

deterrents and compensation to trademark owners is not commensurate with

losses. The main article of Russian legislation currently applicable in cases of

pharmaceutical counterfeits is the one that addresses trademark infringement.

However, the Criminal Code can only be applied in cases of numerous violations

or involving a large damage, and even so the liabilities are inadequately low

($5000 to $8000 maximum). The liability set in the Administrative Violations Code

is even less ($1400 maximum). The Russian parliament has been debating a

potential increase in criminal and administrative liabilities for several years but

nothing has been done so far.

 

[hokeypokey]

In reply to: PJ83 on Wednesday 27/02/08 06:07pm

I plan to do exactly the same... I have been hitting refresh all day.

[wasabibarako]

In reply to: wasabibarako on Thursday 17/01/08 09:32am

I had to go looking quite a few pages back to find my own post to check on my ML prediction, which was for February 8th. So if - as I do expect/hope for - the ML announcement comes through tomorrow, I would just be 20 days (less than 3 weeks) off the mark - not too bad.

wasa

[Torchwood]

In reply to: Torchwood on Wednesday 27/02/08 07:30pm

Sorry for the yellow - hope you can read it. OK so why am I posting. Hands up who was at the EGM. mmm a few of you. You might recall questions being asked re independent directors. I was there and was disgusted with the response from Vagif. Especially the comment about Peter Stedwell being down the hall way in a separate office. Now after you read the article - and with Allco, MFS, ABC learning etc in your memory banks, do you think it would be a good idea for SLA to have some independent directors?

 

If your answer is yes then ask yourself where has all the money come re purchases by Solamind. Given the rather corrupt situation in Russia do you think it rather surprising that Ropren is the only drug approved in the last 20 years.

 

Makes you think doesn't it. Glad those independent directors are asking lots of questions. Sleep tight SLA holders - and don't forget to take some profits on the way.