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Postings here have been very entertaining this afternoon, certainly brightened up my day!!
Pity we slipped back again but as has been said - Friday before a long weekend.....However, I think we are in a good position for when the markets open on Tuesday.
RBT, I agree that people should focus on the fact that the DOJ are 'claiming' that the safety claims made by Ind are not supported by clinical data and therefore promoting on that safety data is illegal. Ind are not contributing to the opioid crisis.
BTW, I am also a scientist and the CEO of a British biotech company (privately owned)!!

Interesting to see that GSK are ditching their flu vaccine program. Perhaps they would like to buy one in!!

Surely we must get some news soon - anything re Flu-V would be welcome and probably stop this death by a thousand cuts!!

Agreed Jimzi !

And Head - I have been in drug development at senior levels for over 30years and as such am fully aware when progress is painfully slow. Flu-v should have entered Ph3 pivotal studies a year ago - at the end of the day no progress is no progress and hence Mon and I taking a tongue in cheek swipe at HVO!

ATB

In addition, there are no active or registered clinical studies for FLU-V at present - so at that rate the development of Flu-v will take...............

A positive RNS issued and what happens..........don't you just love HVO!!

L2 - the reference to an 'Asset' is common place in Pharma and Biotech - unfortunately it does not imply any degree of value.
Having said that FLU -v certainly has a multi M$ value, given the published results. However, that value is being seriously eroded every day that it sits dormant, which it has been for the last 12 months. They really do need to move it into Ph3 or sell it!

Problem is that this statement, 'We continue to make progress regarding strategic discussions related to the assets in this JV, helping to maximise the strategic options available. We have had a number of positive discussions and we are continuing to explore a number of options to enable the continued development of the FLU-v vaccine.',
provides no new or additional information over that we got months ago.
The inflection point here will be when some concrete news comes re the development or sale of FLU-V.

Agreed Jimzi - but as per previous discussions, the major issue for me is that Hvivo will need to raise a considerable amount of capital to fund a Phase 3 program and without a 'strategic partner' I am not clear how they would achieve that.

Got to say that the radio silence is a bit disconcerting. As previous, you would expect some non specific updates along the lines of; 'in discussions with a potential partner or acquirer' etc, if it was indeed the case. No NDA would prevent or inhibit that sort of information being shared.
The clock is ticking and the top line Phase 2b results were released nearly one year ago, we need to see some movement!

mon - this is from the hVivo website:

'hVIVO is acquiring equity in PrEP for £14.0 million cash consideration and PrEP is contracting with hVIVO Services Limited to conduct a £10.0 million Phase IIa clinical programme of work in 2015 and 2016. hVIVO’s investment will be accounted for as an investment in associate in its balance sheet and, in the application of the equity method as an associate, the £10.0 million Phase IIa clinical programme of work will be recognised as revenue.'

Given that the total series 'a' raise was £21m and Jansen have taken equity for granting a global licence for -001 to Prep (likely to be around 10% ish) and the founders will have some equity (could be circa 20%), hVivo are likely to have circa 40-50% equity - please note the above is my best guestimate.

Re development of 001. My best guess is that Prep will not have a huge amount of that left after conducting the 2 clinical studies they were sponsors for. There are no active or recruiting studies registered in Clintrials.gov and therefore we are not likely to see any new data or results in the next year. As such they are in a similar position to hVivo - looking for partner/acquirer and/or another round of funding to move -001 forward.

As always adyor!

Well 10 months ago anyway.

Given everything, it is really hard to rationalise how we are almost back to where the sp was 12 months ago!!

Mon - my thoughts exactly!!! ;)

The competition is hotting up and moving forward:

https://www.fiercepharma.com/vaccines/flugen-plans-further-development-universal-flu-shot-after-phase-2-win?

Big implications across the industry - I know of several drug reviews that are on hold/delayed due to the shutdown!!

Leas, Good call on IMM! Wrt potential 'breakthrough' designation, agreement on primary endpoint and overall requirement for filing and approval- those discussions occur with FDA during an end of Phase 2 meeting. Having agreed these things with FDA it makes the value proposition to potential partners/acquirers much clearer and hence their decision making easier. The EOP2 meeting with FDA costs peanuts in the grand scheme of things and IMO HVO/Imutex have the required skill set and knowledge to undertake such a meeting. Only sticking point at the moment is that FDA is not 'working' at the mo - thanks Donald!

Hi leas, agreed. However, even under an NDA they could still state that they are 'in discussions' with potential pharma partners/acquirers - that would not compromise anyone or anything.

Even with 'breakthrough therapy' designation, I seriously doubt that flu-v would be on the market by end of 2020. In addition if HVO/Imutex thought flu-v warranted breakthrough designation they should/would have already requested it from FDA. If they are in the process of requesting it at an end of Phase 2 meeting with FDA then not sure why they are not releasing updates stating that!
I would really like to see another RNS/press release giving an update on regulatory progress and any information re 'ongoing' discussions with big pharma.

Hi Jersey, Thanks. No they don't have sufficient data. They will have to conduct 2 x pivotal Phase 3 registration studies for regulatory filing and hopefully approval. So getting the nod from FDA that the NIAID endpoint is acceptable for inclusion in these studies as the primary endpoint would be very good news, given that we saw a positive outcome for this endpoint in the Ph2b study. This would also improve HVO's negotiating position with any potential acquirer.
ATB