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http://www.iii.co.uk/research/LSE:OXP

This is moving just like it did Circa 2015. Unfortunately LSE doesn't display the 2014/2015 line and is just a straight line. I will try to find the OXP graph somewhere else, but the 10-20% weekly rises with small dips and then another 10-20% weekly rise is textbook OXP movement. It went down to 3.5p ish and shot to 13p within months. Same resistance was met at 5-6p, and people thought it was pumped and dumped, and shot through to 7-8p and met more resistance, and then shot to the 12-13p line. The only reason this tanked was because commercial partners wanted " a clearer definition of the OTC regulation route " Many potential partners want in on this - they just want to see it proved up a little bit more. This FDA meeting is to do exactly that, in other words, once OXP have a defined route they have to take, accepted by the FDA - we have commercial partners. The likelihood of the FDA asking OXP for a list of minor achievable things is very high The likelihood of the FDA refusing this as a product, is extremely low (It is an old repackaged drug! lol). In other words, this was worth 13p when people expected us to get commercial partnership. It has had minimal if any dilution since 13p was reached, and it is cash happy. I am incredibly confident this will be 15p+ come the FDA news. I also don't see how the FDA RNS can be bad. It is a crossing t's and dotting i's as far as I can see. The FDA will look at what OXP has done, and will simply say "X is good, that's done, Y needs a few bits more there please, Z hasn't been done - do these things and we will pass it through" So long as the Z list isn't insanely large or requires mass monetary investment to achieve, the commercial partners will be happy that a defined route has been established between OXP and FDA.

As for Audits and manufacturing codes I strongly believe this is why they want commercial partners. Those partners will have the necessary sites/plants to manufacture to large scales, and have the experience of Audits and already be accredited by the FDA. Remember OXP is a discovery company - they have yet to state they have a manufacturing facility. Outsourcing your manufacturing is common. In fact it is a legal requirement to have CRO (Contract Research Organisation) to allow for "acts of God" Basically even if you do have a manufacturing plant - if it has a fire how will you supply the needs of the patient? The FDA expect you to have multiple failsafes (basically other companies who are ready to make your drug if rare but serious circumstances are had) These commercial partners will of course be paid, but the patent and intellectual property of the drug delivery system OXPZero will be owned by OXP and they shall yield the majority of the revenue. Why spend cash getting manufacturing up and running when you can simply partner up with those who have been doing it for decades and know how to get it to market quickly? - Fin

So essentially if OXP markets this as a super duper "you get the drugs benefits, PLUS no GI irritation" it will make people buy it over the other brands even if they do not have that specific medical need - which could be seen as leapfrogging the OTC market playing on peoples paranoia about NSAID's and GI irritation. This is why I believe it will be easier through prescription, as a Doctor can make an assessment as to your GI irritation, and means there is no leapfrog potential. I know it sounds crazy - if someone wants to buy a superior product even if they don't need it who cares? People buy ferraris all the time and don't need them. Welcome to Pharma - it is the strictest and most regulated industry out there in my honest opinion, and the FDA take the above matters extremely seriously. If a company is seen to be grooming doctors during its marketing phase, the entire company can be fined and shut down - even if the drug works well! The above of why OTC may be difficult is just a hunch. OTC is by no means impossible, and the easiest solution around it would be to simply market it properly in a way that doesn't cause patient confusion of whether to buy it or another product (like the nurofen incident) Again - just a hunch. Other hurdles are NDA, Now...These are old drugs in a new formulation, so I would have thought they could simply go down the OTC Monograph route of Ibuprofen, rather than applying for a genuine NDA. The likelihood that OXP are not allowed to further a set of NSAID's already established as efficable and work, is pretty much zero. The only reasons FDA will kick up a stink is the OXPZero platform and how it has been managed. So far it seems to have been managed excellently... One other factor is of course, Phase 3 placebo etc. Now, when drug companies make drugs, they have a 1st generation product, and eventually make 2nd, 3rd and maybe even 4th generation products, of similar dosages and same API - just different excipient as it might be nicer tasting, or easier to take (soft gel rather than large pill etc). Companies dont have to run Phase 3's on next gen products. They simply have to do "bridging" studies, which are effectively PK and Tox and if necessary, certain analytical techniques for the new format. Only through significant changes (massive dose change or huge PK change) do you have to do another Phase 3 trial. On this front - OXP have done PK, Tox and the clinical Lanza scores of GI irritation on OXPZero platforms, all passed fantastically. I think only one study failed on one NSAID - but OXP have an entire host of NSAID's to go with and they are always improving that platform so 1 fail out of 5 or 6 or so is actually brilliant in pharma. Statistically only 1 in 1000 compounds ever make it to commercial, so 1 fail out of 5 or 6 is magnificent. To me, in my opinion, these products should be incredibly quick and easy to commercialise.

Okay so, I have some free time lol. Pharma companies when it comes to regulation/FDA meetings are detail heavy, so I will be summarising here. For your run of the mill Pharma company, they discover a new compound, perform toxicology and PK (pharmacokinetic, aka bioavilability) on it, and run it through the usual Phase 1, 2 a b, and 3 trials to get clinical data on whether that compound works - this takes circa 10 years alongside a LOT of money (phase 3's depending on disease can be 100 million PER TRIAL.) Anyway, the main things a normal pharma company discusses with FDA are 1. CMC (Chemistry Manufacture Control) 2. Supply (you need to prove your supply can meet patient demand 3. Toxicology 4. PK 5. IND/NDA 6. Pre Approval Inspections 7. Audits. So CMC. This is essentially collating a lot of data, in accordance with many guidelines (for chemistry, it would be ICH, manufacturing would be the USP or orange guide for UK etc) to show that your product passes all criteria laid down. You need to ensure quality and control on every section of work - Raw materials, processing them, modifying them, making the formulation, mixing the API (Active Pharmaceutical Ingredient) with the excipient (OXPZero in this case), containment, shipping etc etc logistics nightmare. Chemistry controls are there to ensure you have analysed your drug properly and that determines your shelf life eventually, through ICH stressed studies to identify when the drugs potency has failed usual regulations (this tends to be 90% of Label Claim) After these hurdles, the main hurdles are FDA coming to physically visit your manufacturing site, your labs, and to ensure your paperwork etc is transparent and in accordance with all rules and regs. Now, the reason I am extremely excited about OXP is the directors want to access the OCT market (Over the Counter) but have no gone to prescription potentially. The main hurdles with OTC are Supply chain - as OTC sells like hotcakes, especially generic NSAID's. OXP have only ever made intermediate scale batches OTC also needs to pass certain addictive laws.From my knowledge OXPZero and the NSAID's have no addiction profiles, so this should be all good. OTC also needs to demonstrate overdose limitations and that comes back to manufacture scaling on box sizes etc The main hurdle I believe OXP have come across (This is simply a hunch!) is that they are marketing this product to reduce GI inflammation. Now, other than those who react severely and are under doctors supervision or constant GP appointments, how does one diagnose themself with GI irritation from Ibuprofen? Rememeber how Nurofen got in trouble for marketing the same dose of Ibuprofen for different prices to combat different pains despite it all being the same? Yeah, well, the "self use" wasn't clear, in that, customers felt they should buy one type of Nurofen - which is not legal Pt 2 incoming...

Likewise there are many products banned in US not banned in EU - MTBE being a hilarious one. Red tape is always a litigious nightmare where one person is happy and one is not. I was once in a meeting with FDA where everyone was happy around the table bar one person due to ONE reaction seen out of hundreds of test subjects tolerating fine across multiple studies. Comes with the job. However, given these drugs are alreadt available the main hurdle is done. No NDA needed or if it is will be very brief as the drugs already exist.

cluelessss on phone right now but having been audited by FDA and experience of Type C and B meetings with them alongside CMC meetings, I will type out something tonight when I am on PC if I get time - very busy man these days with baby etc. In summary - due to the drus already being approved and have no addiction there arent huge regulation hurdles in this regard. The ball will be in OXPs court to manufacture to code - but thats what the comm partners are for.

Corrupt or not - the FDA are the worlds regulators. You pass FDA you pass most of the planet in terms of launching your product...

Corrupt or not - the FDA are the worlds regulators. You pass FDA you pass most of the planet in terms of launching your product...

Someone said FDA news coming soon. Someone asked how they knew FDA news was coming soon. You said they don't know when FDA news is coming. I stated the RNS states exactly when news will arrive. You then say everything I posted is "known". That makes your previous posts BS and time wasting. We have a troll - anyone got a bridge to put him under? lol

Herman19 the RNS states Q1 FDA news. This is the FDA. Not some permit from some banana republic government, news is definitely due soon from the worlds leading regulation body - fact. As to whether it is good news or bad....OXP wants to commercialise already approved compounds in a formulation proven to work in clinic. This is a crossing t's dotting i's step. Once the reg pathway is set by OXP and FDA comm partners take over. Potential comm partners have already said they want in but just want the reg pathway sorted - which is due this Q1. As for this being a pump and dump -this has been traded on as can be seen, but the dip is 15% from the top and is holding steady and now having a blue day. This is no pump and dump. Pharma with an mcap of 38 mil odd about to go commercial soon? lol peanuts.

is now below the 2.8p first cash raise price. Have a feeling a walk down for mates rates is occurring here.

Correct combo but people were stating the consolidation is ruining the share price. Have to say I did not expect it to drop this much. Either there is a leaky ship and results are terrible or this is declining for mates rates NASDAQ launch. I still reckon this will bag a lot on NASDAQ launch but a shame this isnt picking up much. The decline is happening even without much selling volume so MM's are either collecting shares or they know something red is round the corner. Given the last trial results I cannot see phase 2 failing. Phase 2 only fails if the phase 1 pass is on the edge. We have ridiculously low p values. The trial would have to be 3-4 times less effective to produce a failed result which is highly unlikely.

is holding. Next leg up due soon. Hopefully see some blue days tomorrow onwards. Should break 4/5p mid march if RNS is not out by then in an attempt to get in before FDA news. This isnt some crappy miner with no permit. They have a product that works and are discussing commercialisation and this FDA meeting is to support commercial viability. There is a reason director options are at 10p 20p and 50p and why Neil Woodford invested at 10p, among other big ii's. There is also a reason why when this was over 10p for a good few months no director sold those options despite being allowed to - they know that this is worth more. Directors keeping their options when they are able to sell is a strong indicator.

Looks like 2.9p is the new support line and 3.6p the new resistance. Need some news really. FDA RNS should rerate this

dilution. why is everyone thinking this 150p is different to 2.95p? the mcap is the same - 80 million which is peanuts for a pharma company. Consolidation simply changes share price and shares in issue. Your investment is worth pretty much an identical amount prior to this consolidation

This might dip lower but OXP is very resilient with its movements. 2015 saw a lot of profit taking but it kept its upward trend throughout.

Okay this doesnt look like a normal drop...15% down over just 30 mins. Big sell or just loads of small/medium ones?

Surprised to see this red. Still. 2.7 million sells 800k buys and only ~1% down so MM's definitely collecting shares. A shame we couldnt have an all blue week but the day isnt over yet and its done a good 50-55% so some levelling off was going to happen sooner or later.

5.5p is a strong indicator of a genuine breakout in terms of TA charting. Also 5.5p is OXP's average over 2 years, and whenever news has been slow, tends to be comfortable sitting at that. I bought back in at 6p for this exact reason as I was expecting a double bounce and knew that 5-6p region was key. Got it wrong so averaged down massively just before this rise and so glad I did!