Member Info for Thelix

I am more CMC based than clinical based so it is difficult to answer. My first position would be that it wont take long, but as the FDA require them to assess ulcer bleed rates etc that is going to involve invasive procedures with cameras and all sorts which might slow recruitment. I would say 12 months is a good stick in the sand figure but it depends entirely on recruitment which gets more difficult every year. It is disappointing news I wont shy away from that - but its a time bump in the road. The FDA seemed happy to go forward with a "reduced GI irritation" format so really it looks as if the one and only weight dragging is one clinical trial. Longterm I am happy. I just hope OXP ask for very meticulous answers from what the FDA want from that trial - FDA can be very pedantic so they need to make sure they do everything to the letter.

mikemike take it from someone who works in this Industry and has dealt with the FDA - they have guidelines but they can be misinterpreted or used more strongly on differing occasions. Again - The MHRA accepted the trial data and they used the most commonly used endpoints on GI irritation - lanza scoring. The FDA disagree and want different data. That is what these meetings are for - to iron out any issues and see what else you must do. Even well established pharma get back FDA comments of "no, not happy, you need to do x y and z". It is nature of the beast. Of course the market reacted badly - It is AIM. Could have gone red on bad news too! It is not a company braking results from the FDA and the FDA said they could file for "decreased GI irritation". This is a very viable product with just one trial to get it to market -most pharma on AIM are much further away than that.

It is overdone. 2.2 - 2.5p is still a worthy price IMO. FDA made it clear how to get to market. It requires a clinical trial - bread and butter of pharma companies. What did people think this was going commercial by May if FDA had said yes? Still happy holding here at a slight loss - I might average down but in reasonably heavy already and have a very low entry anyway.

holding steady. Think the traders are out. So in summary, a pharma company has to perform 1 more trial to get FDA IND approval. A bump in the road but will with time go commercial. Given MHRA have accepted the data OXP could attempt to first commercialise in Europe.

Accepted the data. The FDA didn't. It isn't a management issue. This is a pharma company and a regulating body has asked for 1 more supporting trial. This is frustrating news, it is disappointing news, but it is not company destroying news. I think OXP are missing a trick here. Doctors can prescribe "off label" if they think it will help. Just register the product as reducing GI irritation and doctors will gradually realise if it does or does not work. If FDA accept OTC "reduced GI irritation" then OXP should definitely take that offer as OTC is up to the patient not the doctor.

Not selling. Shock horror the FDA requested a pharma company to run a clinical trial to prove the compound. This is a time set back, but once OXP sayisfy the FDA's trial requirements it should go through fine. This will doubtfully slip much more as it has plenty of cash. 1.9-2.1p will be floating for a while. Traders gone tail between their legs smarting. Still happy here.

Jamdo2000 they could do that - but weirdly that could be more expensive and take more time for reasons I will explain when not touch typing on a phone. This is disappointing news BUT all the FDA want is one more study. Jesus christ trust me in the pharma world that is still a sigh of relief. Just get the study done. Again recruiting for NSAIDS wont take long at all.

Now below cash levels. The FDA want ONE study to confirm results. Seriously it means getting to market later than envisioned but its ONE basic NSAID study and we have lots of cash. Once that study is finished and has a good endpoint (which it will as previous similar studies did) then the FDA's requirements will be satisfied. This can still go to market on a "reduced GI irritation" claim with no new studies. They still got MHRA approval and FDA want one study to bolster data. In the pharma industry that isnt terrible news - just an annoying speed bump. It could have been a LOT worse.

mikemike - the MHRA accepted it. IND's always lead to more studies - google IND's. This isn't as bad as people think -just not great either.

They have done GI studies before and they passed them well - The FDA want specific data they didn't get from the last studies. More clinical studies were needed anyway. The FDA have said what they want and OXP have the cash to deliver it. It will not take long to recruit for an NSAID study, and it wont cost a lot either. The reg pathway has been made clear and they are achievable within a short time frame.

It helps that the BoD don't perform the usual AIM pi55taking like endless dilution and promise with no results. The last few years have been very direct with predictable SP movements. As a result - there are few sour people who have been screwed over like 99.9% of other AIM companies.

There was dilution on the 10p placing however this did reach an mcap nearing £150 million. As to other fundamentals - it has shy of £22 million in the bank, further portfolio OXPZero tech to push out, and a low expense format to release drugs in a huge market. Don't get me wrong I am aware this isn't some new blockbusting drug, but OTC and Rx NSAID markets are $billion revenues. Even if OXP gets only 5% of that its hundreds of millions revenue. 20 million Americans suffer with GI issues, where OXP will help. AIM is a startup company market - dont expect FTSE fundamentals from the get go.

the reason the FDA response will see short term upward trend is 2 ish years ago OXP tried to find commercial partners and many were interested but had all the same hangup - Reg pathway. so the 13p dropped as no partner was found. If FDA make a clear reg route for OXP then commercial partners will be on board and OXP are in discussions still. Before FDA response this is a research company trying to sell a product. After FDA response assuming it is good news - OXP becomes a soon to be commercial entity with a portfolio of drugs. I have discussed before the Nurofen-gate and you are right they are being harder on NSAID companies but thats due to their negligence and also why OXP offers a better alternative. That is also why the OTC market is difficult to get due to those issues. Either way, the FDA is a big barrier to which OXP has to pass to get commercial partners. At 32 mil mcap getting partners will see this to 13p+ again. This was valued at 13p on potential comm partners, it should go higher with actual comm partners.

expecting a morning RNS. Maybe this afternoon ?

got me a 350% profit here. AIM is cyclical. He was an incessant poster but I liked his very accurate predictions.

10k here and something is looking good. 2017 has been mediocre so this pulling through will make it fantastic. Good luck all holders and hope we all make a nice bit of profit. Remember don't be greedy! This was valued at 13p on almost getting commercial partners so 15p is a very nice exit price.

went to NT....

The RNS isnt tomorrow. Brexit will drag this down for no reason. The vote sure - uncertain markets yada yada. But markets being this volatile on something known for 9 months is silly. If OXP releases news tomorrow it will hurt the rise.

3.5 trading days left. If nothing comes by Friday morning expect a sizeable sell off as everyone panics. Again, not uncommon for FDA to reply late. They are busy and always have to fit in emergency meetings and schedules. Still confident Rx is in the bag and OTC will be the cherry on top. FDA response may ask for more fast/slow release data to allow OTC market, but other than that should be crossing t's and dotting i's.

It is if the FDA stick to the timeline. They can over run. And take it from someone who has seen both early and late responses - it has seemingly zero bearing on whether it is positive or negative. Also, this isnt an approval per se, but ironing out the regulatory pathway and the IND. Still, if a commercial partner is found after the FDA response then quids in.