Member Info for Thelix

this is barely blue lol. Admittedly revenue will be less as doesn't have the full GI Safe claim but this still has legs considering this SP is still below cash levels!

Yes that is correct. If it works it works, so even if it says reduced GI if doctors after a while realise it works well they will prescribe it. If OTC is same formulation then people will know it works and buy it.

MHRA accepted the design of trial so Europe is a big market and they stated they will be going for it. Still think they should do the trial for US launch

If people know prescriptions are for GI irritation people will biy OTC to do the same thing anyway. If it works it works... Great news - they are going commercial.

Spent it probably lol.

1p would be less than 40% cash in bank which is absurd. The drop is due to uncertainty. The directorate need to decide what direction to go in. The fact they didnt have a contingency plan in the event of FDA not agreeing to the terms and are now spending months making that decision is the reason this is falling. Once that trial starts this will get back to normal.

LOL they are claiming more than better taste. They want to claim NSAID's with no GI irritation. That DOES need a trial. All drugs need a phase 3 trial or a "bridge" trial to show efficacy.

RedX pharma was at a much earlier stage without even any real POC projects. Entirely different. OXP need to decide how they do the trials, once there is more certainty the price will creep up again. Its the uncertainty killing this.

of us got the spike NASDAQ wrong, but glad this is seeing NASDAQ buying now. Admittedly I expected daily 5%'s, but after a spike. Still, only 10p before I am breakeven here now and NASDAQ continues until 9pm odd so its still going! On positive phase 2 intellectual property will see this approximate the ~1 billion mark IF the targets are met with ease. As phase 3 gets into gear next year assuming good phase 2 results it might see ~1.5-2 bil - maybe. There is a desperate need for better asthma and COPD drugs, and we seem to have it. Small advice - phase 2 is harder to pass than phase 1 and phase 3 vs phase 2 likewise. A smart person would topslice a little prior to trial news to remove risk. Depends on your entry and what the price is slightly before results, but it could be as low as 25% to get your money back and let it sit risk free all the way through the trials.

Nothing much to post until more news arrives. As to so called "experts". Nobody has a crystal ball. The trial design was accepted by MHRA. No, that doesn't guarantee FDA approval but getting accepted by MHRA is going in the right direction. Usual oversell.

incline over the next few weeks would be nice. AIM is for traders NASDAQ for investors. Should at least see a more stable price now hopefully.

so not much patience needed my end but am looking at what would be the best entry without "missing the boat". Spread over years or not this company will get nearly £40 million cash in bank and has an mcap of £10m. This has to go up even in the world of AIM surely?

Does a £40 mil contract win allow a drop to £10m mcap? Surely this is oversold or does UVEL have debt or convertible loans to service? Weird one - even for AIM.

Again - the trial HAD to be done so that "burnt money" was going to be burnt regardless of FDA response!! It is the endpoint design of the trial where the disagreement lies. This FDA response will cost the company little extra money in terms of trial design. The unfortunate part is we now have added risk of a trial that may not pass all the endpoints as FDA want a 3 variable endpoint rather than 1. That is the only risk added since the news.

To release the product commercially OXP HAVE to peform a phase 3 trial. The FDA disagreement is on that trials measured endpoints. This needed a phase 3 trial REGARDLESS of FDA agreeing or disagreeing. FDA want better data and endpoints to be reached to advertise as GI safe. MHRA were happy with the trials design. Literally this is all about the design of the trial - not whether this needs one or not - this HAS to have a phase 3 trial to sell. So all this "more cash burn" is nonsense - the trial price is similar regardless of endpoints. The risk is meeting those endpoints. If you have a trial that measures one aspect of GI irritation passing that trial is easy. Two aspects - more risk Three - lots more risk etc. OXP are deciding whether to perform a phase 3 trial to which should pass easily as it is based heavily on their previous trials but limited market access. OR Measure what the FDA want which has never been measured and has potential to fail but if it passes gives us full market access.

Mix/Match doesnt work well in pharma...I'll post why later. At work.

Its neutral news. The different endpoint trial has already been priced in... But this is AIM, so expect either a 50% spike or a 50% tank - or both. This might be volatile today and is a traders dream as it bounces on minimal volume. To clarify - This REQUIRED another trial - The FDA disagreed on the endpoints - not the product. All the FDA are saying is they want OXP to do an amended trial to get the endpoints they want to state GI safety. OXP should just do the trial.

We can have reduced GI. This needed another trial regardless - FDA just want a different endpoint. The RNS has been written much better this time. "Further announcements will be made in due course; the Company remains well-funded to pursue the commercial opportunities available to it". It does have commercial capability and it is funded to do so. Just do the trial OXP, and we can get the ball rolling.

I always thought there was usually a 30 day response from IND feedback with any updates or it all gets passed... My gut feeling is the FDA has already responded and OXP are going through an appeal-like process in regards to OTC. But until official news comes through may as well sit here. This has stabilised well @1.8p. Still a viable commercial product just traders selling up at disappointing news which delays the timelines.

Now NASDAQ showed absolutely no movement this is a sit and wait for phase 2 game. I am shocked and appalled at how this flatlined on its NASDAQ launch. Never seen such a lacklustre performance like that - all other launches I have seen massive price inclines. Ah well cant win them all. Still - a base price of 132p based on huge raised capital so this should stay at those levels and increase gradually towards phase 2 result excitement.