Member Info for D-Geeman

I confess to being puzzled to why they don't lift the lifetime (anthracycline) limit for the trial now since it's been established there are fewer side effects with AVA6K

'the observed durable PR is ongoing despite patient discontinuation due to lifetime maximum dosing'

and then keep people like this on the trial. I imagine this patient would have been more than happy to continue.

If you haven’t listened to this Radon's 4 podcast – broadcast in February – I’d certainly recommend it https://www.bbc.co.uk/sounds/play/m001w13g

'Released On: 08 Feb 2024 Available for over a year

In a week in which King Charles III shared his cancer diagnosis, Amol and Nick ask why it’s important to talk about cancer. Stephen Fry talks about his own diagnosis of an aggressive prostate cancer and we also hear from Paralympian Erin Kennedy, the BBC’s international editor Jeremy Bowen, broadcaster Edward Stourton and from Steve Bland whose partner, the ‘You, Me and the Big C’ host Rachael Bland, died of cancer in 2018. Nick also talks to Amol about his own experience of cancer and they speak to Professor Pat Price, one of the country’s leading oncologists, about why survival rates in the UK are lower than other countries.'

The spotlight series' production values have improved enormously, much more professional now. Viewer is able to concentrate on the message. They seem to have upped their game in many areas.

Everyone always says that big farmer have lots of cash to splash. If they behave like individual people the reason they have lots of cash is often because they are pretty tight fisted, in my experience anyway. I find that reassuring. Otherwise, why wouldn't already have bought out AVCT on the basis of the, still relatively small, amount efficacy evidence we know about so far.

Not that it's particularly important but the algorithm last closed some shorts when the sp was in the 80's.

Trust you are doing OK Mowzer

Seabass, I didn't know what you'd asked of investor relations; AK 123 asked for an update and that may have been regarding the working day question too.

I'm sure they should answer that, or the FDA might / should be able to. Maybe we will know the answer long before FDA would reply to your query.

I guess if the answer came back '90 straight days' that would in fact affect our view of TLSA's position as delays are never good news. 'Working Days' and the sp might well increase shortly. Whether the FDA have responded is actually sensitive info to me.

Airwalk, I've invested in several speculative biotechs and all are 'down'. If I could go back in time I'd have taken a different strategy too. However one I'm in may well pay off and they have cash in the bank. Rua Life Sci. (RUA). Take a look.

Away from biotech maybe watch this interview with Ilika CEO. I don't have a good track record (atm) on making good investments so pls DYOR!

https://www.proactiveinvestors.co.uk/companies/news/1055754/ilika-s-goliath-batteries-exceed-safety-test-expectations-ceo-discusses-implications-1055754.html

'That means you bought in on the LFD frenzy 😂😂😂😂😂'

Me Too...

Like a lot of people on here. Don't people buy shares in companies where they expect high demand for products produced?

'look onto it and get back to me'

I guess they can't give info to one person and not the rest of the market.

'What's happened to watching2?'

– One can always dream....

DD, I just had a thought..

'the agency is committing to respond '

Is 'respond' get into dialogue? Or a 'yes' / 'no' to Orphan.

Airwalk, I see the SP is up as I write $0.87

+0.05

+6.10%

Maybe the wider market will think working days too and start to buy. You might get a bit more before long. You said you only invested a small amount here which is why I guess your holding isn't worth selling. Maybe you'll have a chance to sell soon?

Tils is my second largest investment by original sum invested.

'I wouldn't trust the CEO Cerrone as far as I could throw the guy'

Except he isn't the CEO..

Tiziana Life Sciences Appoints New Chief Executive Officer

Ivor Elrifi CEO Tiziana Life Sciences Appoints Ivor Elrifi as Chief Executive Officer NEW YORK, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”)

GlobeNewswire

•

21 days ago

TLSA

-4.70%

Who knows if they do what they say. This was the FDA in 2017 and announced due to a backlog then:

'As part of this new plan, by September 21, 2017, FDA will complete reviews of all orphan drug designations that are older than 120 days. Following that 90 days period, the agency is committing to respond to 100 percent of all new orphan drug designation requests within 90 days of their receipt by FDA. Program improvements and a renewed commitment to timely review to these critical products will ensure we do not build a backlog of designations again.'

https://www.fda.gov/media/106012/download

I'm assuming working days as it clearly wasn't straight 90 days.. I might be wrong.

If there were a problem with the application then it should fail at 90 days. Then TLSA re-submit when they sort out the problems, if they can.

If there's no problem it should pass and Orphan status granted.

I can't see TLSA and the FDA negotiating after the 90 days has elapsed. So it hasn't elapsed, IMHO...

According to https://www.workingdays.us/#a3 we are today, Sept 9th, on 82 working days since May 13th.

90 working days will be Thursday September 19th.

Mare waiting?

I was on holiday when 'Muck' posted this link on the ABDX BB, with the observation 'Interestingly Launch Diagnostics are, but NCYT (or Primer Design) aren't. '

https://ojeu.com/ojdblnk/view-notice.php?id=3444136

The document title is 'Laboratory Diagnostics, Point of Care Testing and Pathology Managed Service', and 'Type Contract awards'.

Then, as part of a very long list:

'V.2.3) Name and address of the contractor

Launch Diagnostics Ltd

Kent

Country: United Kingdom

NUTS code

UK - United Kingdom

The contractor is an SME: Yes '

I don't know what it means quite and maybe it was also posted here and I missed it.

Personally I would like Launch spun off but still part of the group as I see long term revenue from DX.

Courtesy alextak

https://www.fool.co.uk/2024/09/07/is-avacta-the-best-ex-penny-stock-to-buy-today/

LDA, I just read this though doesn't give definitive answer, and more USA, and the scenario is fired CEO rather than CFO moving on:

https://www.quora.com/Do-CEOs-lose-all-shares-and-stock-options-granted-to-them-by-the-board-of-directors-if-they-are-fired-from-their-company

Just a reminder from May 13th release:

'NEW YORK, May 13, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has submitted an FDA request to obtain Orphan Drug Designation for intranasal foralumab.

….

Once submitted, applications are reviewed by the FDA’s Orphan Drug Designation program, which determines whether all criteria for Orphan Drug Designation approval have been met. Applications are reviewed by the Orphan Drug Designation program within 90 days of receipt.'

Enjoy the garden Touk! Raining with us...

I don't think the FDA would just ignore an application for Orphan drug status.

People here assumed, understandably, that it would be 90 days (and the wider market thought so too, hence the rise in SP) but now it looks like '90 working days' which takes us into next week.

Or the FDA will have missed their own deadline and we wait longer..