Member Info for Treeshakers

It certainly reads well. You would have thought that one of the big US players would step in snap the company up for the patents and technology - it would be pocket change to them..

Aren't we supposed to hear if the CHMP recommendation this monthm after the expert panel announcement? The.monthly CHMP meeting was this week.

More selling from Obotritia. Looks like they may be dumping their entire holding. This is the 3rd RNS in succession.

Jim. I think the science is promising but I am not buying back in now. Given that there should be fresh data in January, posssibly the xmas lul might be a better time -.and we will know more about the effects of Omicron by then.

Krystal's NDA won't be submitted until next year and likely well after Amryt's revised PDUFA date. FDA will only get to review the data upon submission.

The PDUFA date is Nov 30. This is the expected date for a decision. I believe FDA meets around 90% of these targets.

RNS today states that they have now received regulatory approval to continue in all locations. This means , even if there are.no further hitches, that the trial data will not be available until Q1 next year.

Looks like jCyye have already completed their repeat dosing trial at least judging by the status shown on .clinicaltrials.gov site. That will allow them to move into the pivotal phase 3 study next year. Great to see cell therapies progressing through the clinic. RP sufferers must be hopefull that a treatment is getting closer.

Thanks Phil. Fingers crossed!

Anyone know if they have reopened Oxford or Barcelona? Clinicaltrials.gov says the sites are still not recruiting.

My main takeaway was that they have 22mi n cash which, at their current burn rate, would last 2 years. I therefore don't anticipate a cash call until some commercial deals have been signed.

The.prospective cash call was the main drag on the SP last time aroumd.

It does sound like they have made progress on exosomes and it aeems reasonable that, after establishing POC, further optimization is required. As was stated, it's an iterative process involving RENE and the partner(s). Olav stated that all the collaborations were with much larger companies (he has previously described some as household names). If RENE's exosome tech proves a winner I could see a partner buying them out to gain eclusive access. CNS drugs can commamd extraordinary sums - ask Biogen!

So my question about CTX status was the first in the Q&A session today. Olav's answer was that Fosun have been concentrating on tech transfer and manufacturing. Unlike some China deals where the drug or.biologic is imported, Fosun have chosen to produce in-country. He also said they were very committed to the stroke program, principally because of the high rate of smoking in men in China. This is a known contributory factor in stroke.

I would have liked more info on recruitment into the trial but he eithwr doesn't know or can't say (probably the later).

Oh no! Morebgood news - no advisory.committee required!

I listened to the presentation. Disappointing to discover they have still only treated 3 patients in the Ph2a trial. They received permissiin from the regulators last June so progress has been slowl. Olav is still promising that Barcelona and Oxfird will open "soon" just as he did in January.

https://www.thetimes.co.uk/article/china-has-left-the-west-behind-in-the-21st-centurys-gold-rush-svgt9f6w6

He has finally put away his powerpoint slide deck after 20 years!

For those interested in the stroke indication, it's great to see a medical device (rather than a drug/cell therapy) being developed in Israel. This is being targetted at patients with chronic stroke disability similar to CTX before the program was discontinued.

"BrainQ gets FDA Breakthrough status for its device for reducing disability following stroke"

Israel is certainly anl major innovation hub. They have now produced a medical device targeting the same indication that CTX was supposed to address (before the stroke program was discontinued). Not only are they great innovators but they understand that getting a product to market quickly is just as important and the science..

BrainQ gets FDA Breakthrough status for its device for reducing disability following stroke

The problem Shield have is that they outlicensed the drug in Europe. They gave up all in return for an upfront payment and royalties. They licencee decides how investment they are going to put into marketting and applying for reimbursement in Europe fragment market where agreements have to ne negotiated with each country. Royalty revenues from Europe were £700k last year. That doesn't evem cover the cost of employing the CEO when you add.employer taxes. This is not a viable business.

There is potential for significant investment from renewable energy funds but I would expect them to hold off until the prospects of success are better understood. The upcoming release of the Business Plan should act as the catalyst for institutional buying.