Member Info for Bella6532

Https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program

'Rising wealth in emerging markets is boosting healthcare spending, while advances in gene therapy and editing are opening doors to previously untreatable conditions.

And that’s before we get to the looming patent cliff. Blockbuster drugs still generate over 80% of revenues at pharma giants such as BMS, Eli Lilly and AbbVie, but once exclusivity expires, generic versions can erode up to 80% of sales in the first year.

Deloitte estimates that 190 drugs will lose exclusivity by 2030, creating a potential $240bn revenue gap, with Novo Nordisk’s Ozempic among the high-profile names facing patent expiries over the next decade.

With big pharma sitting on a $1.3trn war chest, biotech has become the prime hunting ground for replenishing pipelines. Biotech firms now deliver the lion’s share of global drug approvals, powered by nimble, capital-light research and development (R&D) that slots neatly into pharma’s global sales and distribution networks.

That said, it hasn’t all been plain sailing. Some investors sat out the initial turbulence around tariff and concern over the Most Favoured Nation drug-pricing and changes at the Food & Drug Administration (FDA), which regulates drugs in the US.

Despite this, the drug approval process has ticked along steadily and the FDA’s pilot ‘national priority voucher’ program aims to cut approval timelines from a year to just a couple of months.'

LDA..no they put gravy on their grits...

The results can wait two more days at least. Thanksgiving for Americans is a huge one and she will have timed everything around it. My guess is she probably spends more time Stateside than you realise.

Thanksgiving in US tomorrow.

RNS next Thursday perhaps!!

Https://www.fiercebiotech.com/biotech/gilead-hatches-400m-biobucks-deal-swedish-biotechs-trex1-cancer-program

BV..I don't know because it happened in France. He and his wife were told that there were drugs which might help with the symptoms but they had no way of switching the system off... it was just fingers crossed and hope that it would stabilise itself which in some people it does. The consultant said it was rather like allergies...some people react really badly and it can lead to death.

Yes and ghey played down the side effects...not good...I know someone who suffered fron CRS after his cancer treatment and it killed him because they had no way of turning it off and it just got worse snd worse...and the onset was rapid once it started.

'Patients experienced mild to moderate side effects from the treatment, with Cytokine Release Syndrome the most common side effect, which happens when the immune system goes into overdrive after treatment, causing flu-like symptoms.'

Basically the body starts to attack itself...no not a wonderous new drug in my book...

Most common side effect is cytokine storm:

Symptoms include fever that tends to fluctuate, fatigue, loss of appetite, muscle and joint pain, nausea, vomiting, diarrhea, rashes, fast breathing, rapid heartbeat, low blood pressure, seizures, headache, confusion, delirium, hallucinations, tremor, and loss of coordination.

Universities looking to sell the IP...

They've been pushing the narrative towards the markets/investor publications/online sites because they were targetting investment not sales...

????

And they got FDA Fast Track in August...that's worth a shed load to US based companies right now...

https://haldatx.com/halda-therapeutics-receives-fda-fast-track-designation-for-hld-0915-for-the-treatment-of-metastatic-castration-resistant-prostate-cancer/

Truth is, we don't know exactly what it will be able to do as these P1 trials are safety trials not efficacy trials. The patents are seriously ill (terminal) and pre-treated so difficult to say how much resistance the cancer crlls have established. Now we do know PreCision does it's job and has targetted the tumours snd released the payload as it shojld have done however as far as efficacy is concerned late stage pstients are not necessarily going to respond well to the payload. Now this is where P2 is crucial and what Pharma will be wanting to see because they will be able to make a better comparison in patients who haven't been pre-treated and at an earlier stage of diagnosis. Knowing what we know do far the first data sets should really get their attention and secure some initial deals.

I also think another fundraiser in the New Year to buy down more of the bond is a given.

It was a buy and a sell... someone bought shares from whoever was selling....or someone sold to whoever was buying....

Https://www.labiotech.eu/biotech-deals-2025/

Huge deal value but only represented 42% increase to SP...so be careful what you wish for guys...

https://www.fiercebiotech.com/biotech/novartis-ceo-paid-top-dollar-avidity-become-leader-neuromuscular-diseases

Oops!...should read...

I still think deals are based on Bond reduction...it's an overhang they don't like...and this para seems to hint at same..

'Upon the earlier of (i) the date on which the Company publishes the data readouts of its Phase 1b trials of faridoxorubicin (FAP-Dox, AVA6000) in triple negative breast cancer and (ii) 30 June 2026, the Bondholder will have the right to accelerate the satisfaction (in cash or shares) of one of both the Deferred Repayments and in addition, from 1 October 2026, at any time accelerate the satisfaction of the quarterly repayments on the Convertible Bond, subject to a maximum of one acceleration per quarter.'

I still think deals are based on Bond reduction...it's an overhang ghey don't like...and thi para serms to hjnt at ssme..

'Upon the earlier of (i) the date on which the Company publishes the data readouts of its Phase 1b trials of faridoxorubicin (FAP-Dox, AVA6000) in triple negative breast cancer and (ii) 30 June 2026, the Bondholder will have the right to accelerate the satisfaction (in cash or shares) of one of both the Deferred Repayments and in addition, from 1 October 2026, at any time accelerate the satisfaction of the quarterly repayments on the Convertible Bond, subject to a maximum of one acceleration per quarter.'