Netscientific Share Discussion Threads

[zen12] 03/10/2022 14:34

Well it's in the bag now! We all know how difficult FDA can be getting through level 2 is a massive achievement..!

[blakieboy7] 03/10/2022 14:31

TIDMNSCINetScientific PLC03 October 2022NetScientific plc("NetScientific", the "Group" or the "Company")PDS completes End-of-Phase 2 meeting with FDANetScientific plc (AIM: NSCI), the international life sciences and sustainability technology investment and commercialisation Group, announces that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab) for the treatment of unresectable, recurrent/metastatic human papilloma virus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC).Earlier this year, the FDA granted Fast Track designation to the combination of PDS0101 and KEYTRUDA(R) (pembrolizumab) for the treatment of HPV16-positive HNSCC. The FDA's Fast Track designation program is designed to aid in the development and to expedite the review of drug candidate applications that could potentially treat serious or life-threatening conditions. Treatments granted this designation are given the opportunity to have more frequent meetings and interactions with the FDA throughout the entire drug development and review process, with the goal of moving promising new drugs more rapidly through the process.Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech commented: "We are very pleased with the guidance received from FDA on key elements of the clinical program that will support the submission of a Biologics License Application (BLA) for our lead asset PDS0101. The interim safety and efficacy data we presented to the FDA has allowed us to move into a registrational trial ahead of our projected schedule. This, along with the recent capital raise, allows us to efficiently advance our clinical programs."PDS0101 represents a potentially transformative treatment approach for HPV16-positive HNSCC patients. We are committed to providing physicians and patients a possibly more effective and safer treatment option to address this debilitating and deadly disease."Dr. Ilian Iliev, CEO of NetScientific, commented: "We are pleased with PDS' continued and systematic progress on its business objectives, despite unfavourable capital markets conditions. Building on momentum from the FDA Fast Track designation in June 2022, and the subsequent $35m venture debt facility in August 2022, PDS is now well positioned for further progress in its PDS101 clinical programme."

[blakieboy7] 03/10/2022 14:31

It's about bloody time!!

[zen12] 03/10/2022 14:10

RNS out!"PDS0101 represents a potentially transformative treatment approach for HPV16-positive HNSCC patients. We are committed to providing physicians and patients a possibly more effective and safer treatment option to address this debilitating and deadly disease."

[kingston78] 30/9/2022 14:09

The CEO has commented, " We have a well-balanced portfolio across sectors and geographies, with businesses at different stages of their development, and adaptable for a changing sectoral and macro-economic dynamics. Within several of our companies, we are working on substantial liquidity events or routes to exit."

I look forward to the days when the company sells some of its investments at substantial profit.

[blakieboy7] 30/9/2022 09:19

Agreed loaf, they should be buying now

[btgman] 30/9/2022 08:14

Share price 1/3rd of NAV one would argue strongly that this is massively undervalued

AIMHO
GLA
BTG

[blakieboy7] 30/9/2022 08:14

Nothing new in results

[blakieboy7] 29/9/2022 09:50

It's a sea of red across the board sadly

[loafofbread] 29/9/2022 09:43

Q BOT have just been awarded a £800K research grant.

You would think that might be something the company would tell us as the share price reaches all time lows.

[loafofbread] 27/9/2022 08:19

In theory we should be getting notice of results/results asap.

[blakieboy7] 26/9/2022 14:34

We really need a good RNS to stop the rot

[loafofbread] 24/9/2022 19:32

Looks like I have a fan out there who keeps marking my posts down.

Could be the chairman, who makes Trump look truthful!

[blakieboy7] 24/9/2022 15:10

This was from the May RNS - Hence, ProAxsis is now delighted to confirm that the necessary work for CE Marking has been completed and as such, a notification has been sent to the MHRA. The company expects acknowledgment of receipt from the MHRA shortly, which is a prerequisite of market launch.So 4 months have passed and still no acknowledgment?!

[loafofbread] 24/9/2022 14:16

All of the above posted by tqhussain on lse.

Quite why we have radio silence from ProAxis and NSCI on a actual CE Mark and product launch is beyond me.

They first discovered this new process based on the direct measurement of a product of the biochemical process of natural bone degradation. They then started the development of the ELISA test in 2014. HUG and UNIGE filed an initial patent in 2016, following which, the potential and quality of the test interested the company ProAxsis Ltd, based in Northern Ireland, for a license in 2021. The test received the CE mark in June 2022 for marketing in Europe.

‘It is not often that a product developed in a university hospital is marketed. And even less so in such a short time! We owe it to the excellent collaboration with our partners,’ concludes Serge Ferrari.

[loafofbread] 24/9/2022 14:09

A new device for diagnosing bone fragility invented by the University Hospitals of Geneva (HUG) and the University of Geneva (UNIGE) has been approved for marketing in the European Economic Area and Switzerland. Licensed by the Northern Irish company ProAxsis, it has been launched this summer. The device is based on a new approach to assessing bone quality via blood sampling. This test is much more specific than current techniques and will significantly improve diagnosis and advance the development of new treatments for osteoporosis.

[sev22] 20/9/2022 20:51

NetScientific portfolio company PDS Biotechnology to advance lead candidate PDS0101 with term loan:

[loafofbread] 14/9/2022 08:26

Company not worth much more than the 2 recent cash raises. Lots of explaining to do in the soon to be results. Get a big backer involved in a QBot raise and bank some money would be my starter for 10.

[blakieboy7] 13/9/2022 14:52

Wow! 47p now ffs