Member Info for mikemike

i disagree Churchill arranged a police investigation of the documents. the police confirmed no forgery took place. They would have noted the auto pen during investigation. If the use of auto pen was incorrect the police would have identified this?

So if they follow the FDA suggestion, this could with a partner be available at any time, or does it have to go back to FDA and if so how long does that take. In the meantime they get on with a clinical study to provide the evidence the FDA want for removes irritation with bo issues on bleeding etc. This would be a two year path?

will be that the legal council for the claimant just does not understand us, we covered all their points to our satisfaction....so there!!!! When you have automatic self interest like forming your own panel who are known to one of the arbiter as ''peer person'' Does make you wonder Should the reviewing panel go after '' route 1 protect self interest'' where then? Can the panel be taken to court for deliberately, knowingly and willfully ignoring and obfuscating the complainants appeal? I ask that as it seems to e that is their only option. As that is too obvious they will play the game with a nod and a wink hear it all and say 'nothing new here, it is all covered to our satisfaction' etc.

thelix Good to know you are industry based/ How long would you expect a clinical undertaking to be completed? I would be very surprised if the ''clinical'' would be a standing start, bearing in mind how far this process has come and gained MHRA aproval

No i think people expected that the procedures for FDA approval would have been better understood. By may it may have been possible to have had the other approvals as well as an indication of partnering. Before anyone says anything about this not being a significant failure BOTH the FDA and Mr Market say otherwise. That it can be corrected does not take away legitimate concerns around the business management skills. I am confident that that this will be a steep learning curve in this regard and this will be accepted as a challenge to do much much better As with anything, people in position of responsibility are held accountable, not just when it goes right. Some may think this is harsh, well this is a commercial venture and it will be judged harshly. Both the FDA and Mr Market have spoken. I am sure the BOD have listened and will deliver to meet expectations. I do not expect any of the BOD to 'fall on their Sword' I will be looking closely at the next relevant RNS to confirm this understanding.

bearing in mind that CC have placed the records in the public domain including the written transcripts I wonder why they did not identify the full wording of the threats made against the witness by the ROI as reported in this appeal. I agree with CC that the timid/ tepid response by the arbiters to such a clear and obvious threat is in itself a cause for concern. Why did the panel not take this seriously??

bearing in mind that the ROI have admitted that it is down to an ''insider'' Inside by definition is an ''official'' begs the the question ''How can you forge your own signature''

papers are posted

maestro i suspect that ICSID and ROI will receive the documents and then be advised that they have a certain number of days before the document is placed on the web page. All part of the pressure that needs to be applied to ROI, gives them an opportunity to contemplate the least worse face saving option. Or, accept they are in for a no holds bar brawl conducted in public.

I would suspect that Churchill have to give a copy to ROI as part of procedure. When they have to do that Will probably be at the same time the original is submitted, they would not have to get permission from ICSID. In saying that the arbitration process may not ask this !! We do not know what we do not know.

Reality is anything can happen Should that happen again then its clear that despite the Bio science being world beating. Management of process leaves a lot to be desired, it is a different skill set. I would have expected that the FDA issues a ''template'' which allows the FDA to tick boxes for evidence. That testing would be required has come as a surprise. In saying that,there are options to take a step along the correct path whilst ensuring that ALL FDA process and requirement is fully understood and delivered process with ''form & substance'' water tight. Many a slip between cup and lip. The BOD will be costing the process against the bank balance. The next RNS that lays out the route is going to be interesting.

Maestro that the company ''believes'' is a given. As history proves, ''belief'' sometimes needs more . If we get a funder and it is a BIG IF I suspect they will be part funded on placement basis, who knows!!

Anyone like to provide a time frame to produce the FDA requirements, I suspect not less than 12 months

doubtfull this will go below cash value of 1.6p

Somewhat fundamental ''The FDA has indicated that in order to support an improved gastro-intestinal ('GI') safety claim, a clinical outcomes study would be required, including measures such as assessment of the incidence of peptic ulcer bleeding and related complications.'' I am surprised that they even considered putting this in for approval

Suspect the news will go badly. What concerns me most is that the identified points of concern are somewhat fundamental to say the least. Oh well back into the lower draw for at least a year maybe more.

they also have 20m£ in the bank and no debt exec options are aggressively priced all the way up to 50p

majority of stock is owned by institutions not PI, so sentiment is out. Neil Woodford, fund manager with a great track record has a significant holding here as your research will have shown. I still believe your questions are best directed to the CEO, he is more than happy to respond.

Amazing first post Why not send this to our CEO and get his professional response, rather than relying on a BB.

still have one day to go until end of the month