Member Info for Thelix

An FDA rejection. It was asking for extra data to launch under a specific definition. FDA accepted reduced GI terminology. This is a definition/semantics issue - not a product/work poor standard issue.

are not priced forwards rhodi. Again. GWP diluted by 100% and it multibagged on the first day of NASDAQ. The British ii's got similar prices. Thats just business.

around 2.8p old money as per the last cash raise. To be fair if I were a US investor I would want in at a similar price every other ii got in at.

LEG does this dip rise wave every time. Traders dream this share.

has no cash - the price is rising for a placement.

Ehhh. The European market has aggressive price marking. In my experience of the industry most European nations refuse to pay until the price drops to barely any profit margin. It would be a struggle to get even tens of millions £ revenue. Pharma exists purely on US sales. USA pays for the rest of the world to have cheap medicine. Sad but true. There are other markets available but some are even tougher than the FDA. The asian market is brutal - Japanese regulators are even stricter than FDA.

rhodi - incentive scheme? Care to share? Yeah this will blatantly go through mates rates. Very disappointed in the BoD at VRP. Still holding to get that hopeful NASDAQ rise but I have significantly downgraded my expected profits from this.

Yes, they could/can market this in Europe. You can then launch via something called the "MRA" or Mutual Recognition Agreement. The downside is the world market gives less revenue than the US market. US pay a lot more for drugs so drugs companies like to launch in US. This seems to have moved up a bit again.

The OTC feedback comes soon. Hopefully they give the same offer - can sell at "reduced GI". OTC reduced GI will still sell like hotcakes and bring in annual revenues multiples of current mcap.

Agreed it isnt bad. Its disappointing - its a delay. The FDA however gave OXP a route. That route simply needs one more clinical trial. Bread and butter of pharma. This is a huge over reaction. It is a shame, but in no way affects the products capability. Hope the trial is done asap and watch this rerate.

MTT had OXP got the data the FDA wanted then they would have been able to progress further. It can take years, but it depends what you are trying to get onto market.

1p will be valued at 55% of cash in bank. If this goes to 1p I will definitely be averaging down. I can't see how it legitimately can fall much further given cash levels. Either way, this has changed from short term to medium term hold.

rise no RNS and has almost nil cash and is at end/start of tax year. Placing inbound

Average time for pharma to go commercial is 10-15 years. OXP have a potential 12 month delay and everyone loses their minds. Its a viable product and needs 1 more trial. Seriously this isnt in that bad of a place, its just unfortunate of that 1 extra trial we need. Did anyone bother to read up on IND's? IND's give companies permission for clinical trials. Got to laugh. This is still a short term (for pharma!) holding.

For the 3rd and final time - The FDA requirements are not a set in stone format with which you get 100% success rate. Every situation is unique, and the FDA list guideline criteria. I am telling you now even the big pharmas who have been doing this for decades sometimes get similar FDA feedback at the IND stage. This is not a BOD issue. In AIM mr market can definitely be wrong, though the floating 2p is fine with me.

I would assume and I think the market had already priced in the RNS being almost identical. The worst outcome is the FDA state it does not have the capacity to go to OTC period for reasons x y and z. I am expecting an almost identical response. Then again I said prior to the RNS it was almost guaranteed. The MHRA did accept the clinical data. OXP havent been negligent or unprofessional or underhanding in any way. This is a genuinely just difference of opinion between two regulating bodies. It happens in this industry unfortunately.

Quite a few more FDA encounters to go no matter what route they take (reduced or removed GI) but that would be more NDA (which I need to figure out as this isnt a new drug but would have to go through similar stuff) and then a PAI (Pre approval Inspection) before commercial. The way I understand it they want to outsource commercialisation to a partner. Sensible and cheaper as they will probably already be an FDA accredited site and wont need a PAI. This *could* be on the market within the next 2 years. I know that sounds ages away and why would SP rise on no revenue but remember a certain pharma by GWP code was valued at 2.5 billion with no revenue lol. If a partner is had and a product locked down - this will rerate. If it enters the fuzzy "yeah were gonna do the trials" this will be at the mercy of the market - dips and spikes. Rx OXP shouldnt go for reduced GI in my personal opinion OTC OXP should definitely go for reduced GI in my personal opinion. But I am a lowly CMC guy never made those kinds of high level decisions before so take away what you will from that. I am not selling here at all. Happy to see what OTC RNS is like. Even then - 1 trial left is late stage pharma. Some pharma here is more than 1 trial away and worth more. Onwards and upwards hopefully.

of 75 mil with most NASDAQ pharmas being in the region of 0.5-1.0 billion I would say just IPO at a 125% dilution. GWP did a 100% dilution and it skyrocketed. Since then they have raised more cash and equates yto ~155% dilution. Went from 50 mil mcap to 2.5 bil at one point. The AIM will see this drift and mess about and American investors arent going to pay AIM spike prices. Even if we get the endpoint study and it passes this will spike for a day or two and drift down as AIM always does. US investors will want to buy at a 120 MDA or something similar. Just get on with it.

If FDA say they can launch it under "reduced GI irritation" I say GO FOR IT! Does bill and bob down the road know or care about bleed rates and lanza scores? End of the day if mr public has GI irritation and they see a "REDUCED IRRITATION!" product they are more than likely going to try it and use it. Whereas prescription a doctor will understand the data and be reluctant to prescribe something that may only work to a moderate level. OTC is a nice easy market with easy revenue - hence why OXP want OTC over Rx. If FDA say go ahead with OTC at "reduced GI" and a partner is happy to be part of it then that will save us a lot of time.

Ah Mert i was meant to answer that yesterday. It can be done - but I would recommend against it. Currently most/all NSAID's irritate the GI so OXP's filing is pointing out a big gap that is easily defined and justified. The issue with releasing reduced GI to full "No GI irritation" is you have tightened the gap to which the medicine has a clearly better effect towards patient needs. Basically OXP would have to fulfill more stringent tighter specs to justify the 2nd gen product. If the 1st works well enough for patient needs why release a 2nd gen which only improves it a little? Secondly, the time it will take to go through filing and audits and commercial scalability and packaging for reduced GI product the trial will be finished and if it passess all that previous work needs updating and changing. So its a difficult risk/reward decision. Pharma takes a long time and is very letigious so generally speaking they go for a risk assessed approach and have clear defined goals. Again, the fundamentals here are this is a company with official feedback that its primary goal to go commercial is one more clinical trial. To me, for an AIM pharma at an SP at cash in bank is a BARGAIN. The previous clinical studies passed very well and there is nothing to suggest this next one will not pass in the same way.