Member Info for sajy

In the interim results in Sept 2021 the company said more than 50% of patients had been enrolled in the phase 2 trial. I think it is therefore reasonable to assume that we should get an Rns in March confirming the dosing of the last patient in the trial. With already having completed 3 trials in Russia and gaining approval, the phase 2 trials should meet the end points.
I am hoping that we will then sign a licensing deal with a pharma to fund the phase 3 trials for USA and Europe.

Sng's poor results just go to show how risky it is to invest in pharma. Polx also carried a similar risk when they applied for approval, however I believe the risk has now reduced considerably after the CRL. My understanding is that the tasks in the CRL letter are pretty straightforward for the company to address. When the company resubmits for approval, the chances in my opinion will be very high to gain approval this time.

Agree Burylad, you could tell he was very annoyed at the FDA and the fact that Amati still have a large holding in Polx shows how confident they are. They will know more than us PI's. I'm very confident that a resubmission Rns is imminent, hence me building a large position over the last month.

Burylad, I am expecting the resubmission Rns sometime in March. I would be surprised if we got it this month. Not long to wait now, we are nearly there.
Also if you watch the video, the guy from Amati spells it out that polx were only given an CRL because the FDA ran out of time as they were too busy approving Covid tests and vaccines etc and wanted more time. That ties in with what I thought and tasks in the CRL are quite straightforward for the company to complete.

At a Mcap of £18M surely OVB must be a sitting duck for a takeover target. We have approval in Russia on the back of data from 3 trials. We have a phase 2 trial nearing completion, which will have a very high chance of meeting the end points. Then all we need is one phase 3 trial to gain approval for USA and rest of the world. OVB is ridiculously undervalued and hence very appealing to other companies.

What a great day today thanks to OVB, did over 100% and expecting it to open even higher tomorrow.
Polx will be next when they announce the resubmission this month. It won't do 100% but still expecting a very decent rise on the day.

The market has got this wrong, It is way too cheap at this price. Just look at the likes of fum to compare. I suppose releasing an Rns at 15:30 didn't help. This should be in all the papers tonight and won't be surprised if it opens into the 30's tomorrow. It's been a long wait but worth it.

Two hugh buys just gone through.

I have now built a substantial position here over the last few weeks. Next month we should see an RNS confirming the resubmission. The FDA then could take 2 or 6 months for approval.

What a plonker! Do some research.

Had a chat with Dr Martin Hall of Harman & co. He was very impressed with the China deal and believes the next deal will be for the USA. He thinks the next bit of good news will be FairJourney supplying the antibodies.

Hopefully me buying will have helped the cause.

It's called research. If you have anything remotely interesting to say I am all ears.

Hi Thompi, I have got a feeling it will be 6 months, but I am not sure and am trying to get it confirmed. If I find out I will post it here, but take it from me the resubmission will be before end of Q1.

This will be my last response and I wont be wasting any more time trying to justify myself. Stifel stated that the company would be requesting a type A meeting with the FDA and would then be expecting to receive approval late 2022. The company have said it would take about 6 months after the resubmission to gain approval. For that to happen the company needs to resubmit before end of Q1 as I have said. If these timelines had changed the company would have had to issue an RNS. Also like I said it helps if you ask the right questions.

Gam2 I hope you will be man enough to apologise to me when the company issues an RNS and proves me correct.

Hi pjmcgra, I can understand you questioning what I have said. All I can say is that I have no reason to lie and my research is as mentioned in my previous post. It's difficult to believe what is posted on these chat boards, but it's not long before the end of Q1. The company will have to issue an RNS before end Q1 and you can then decide whether I was telling the truth or not.

Reading the companies RNS carefully to understand what they have said they intend to do and if they don't do what they said, would they need to issue an RNS. It also helps by asking the right questions.

If you do your research like I have then you will be able to confirm everything I have said. Alternatively wait for the announcements from the company and you will see I was spot on.

I can confirm that since the CRL last year the company have met with the FDA to discuss what is required for resubmission. The company intends to resubmit before the end of Q1 with the necessary changes to gain approval. Approval this time could take between 2 to 6 months. I have been adding.