Our latest Investing Matters Podcast episode with QuotedData's Edward Marten has just been released. Listen here.
https://www.terrapinn.com/conference/world-antiviral-congress/index.stm?_ga=2.257983050.1981582607.1658355129-474517177.1658355129
https://www.terrapinn.com/conference/world-antiviral-congress/speakers.stm
Phillip Monk is a speaker at the
World Antiviral Congress 2022
Bringing translational antiviral drug discovery and development to the market
28 NOVEMBER - 1 DECEMBER 2022
LOEWS CORONADO BAY RESORT, SAN DIEGO
IMO RM is urgently pursuing an EUA from the US. They have our data from hospital P2, hometrial and firsthand experience/data from Active 2.
RM communicated over a year ago about the possibility of gaining EUA ahead of completing PH3 hospital.
Such a move might suit all parties at the present time. Gives the US first dibs at available stock and for us takes the pressure off active 2 result by more than compensating any ‘flat’ result wrt SP.
Would potentially further de-risk PH3 hospital and make the run-in more exciting starting from a much increased SP??
Good informative post Seaboy - thanks for taking the time.
In your opinion, how long might it take to release HT results RNS post 90 day follow up completion?
I am thinking they will have the RNS 99% complete now, slot in the last 90 day follow up that they should have today(?), then issue in the next couple of days? Is this view too simplistic?
We have been told summer (July/August?) for PH3 completion. 'Data is king' and as demonstrated in the PH2 hospital and HT they will take all the time they need to recruit the most suitable candidates.
However, RM recently talked about the possibility of being granted an EUA ahead of completing PH3, providing the company commit to completing said PH3. RM comes across as someone who takes great care with what he says so it would seem a strange thing to divulge if he had'nt been having such discussions?
If the main reason for not having EUA already was due to trial size of PH2, then we just need to recruit PH3 to an agreed number when the data monitoring committee can complete an interim analysis. Maybe the UK PH3 (already Circa 2 months in) will provide the necessary data to enable the above scenario?
W.r.t ACTIV, I like everyone here, would appreciate confirmation that 'summer' completion is for PH3, not just PH2!!??
As regards PH3 primary end points RM has said "The goalposts are slightly narrower - but we have 2 shots".
Post PH2 Prof Tom W said that proving significance in hospital discharge was difficult as different doctors in different hospitals with varying virus pressures introduced a lot of subjectivity (or words to that effect). However, RM wouldn't have signed up for this in PH3 if he didn't believe it achievable? Maybe hospital re-admissions will be taken into account?
Would prove the economic case for SNG001 if a cost saving is demonstrated through earlier discharge.
......... and when 1st dosing RNS(s) land what are the chances of them including details of conditional pre-orders from US and/or UK?
I can't see either agreeing to 'urgent' or 'fast-tracked' ph3s without securing an immediate supply should they corroborate ph2 results?
What would a conditional order of say 200,000 treatments from the US do for our SP, as well as create FOMO in the UK?
RM did say we should expect 'chunky' RNSs - so I'll keep my fingers crossed for an early Christmas present!!!
GLA
Hi Ghia - like many here I have considered the US as the 'elephant in the room' for some time. This is the first time I have seen 400 mentioned as the recruits for ph3?
Has this been confirmed?
I was under impression it was 900 total with 200 in host country and 700 across other 20+ countries?
W.r.t. COPD results IMO they are more likely to be good than bad....
1) if the data was really bad surely they would not still be analysing it and we would have been informed by now?
2) if it was inconclusive might we have been told they intend to recruit the remaining 11 people and complete the trial this winter?
3) The qualified guys on ADVFN explained that there are more end points on the COPD trial v hospital trial and would therefore take longer to complete analysis. Again - if they still working on it I believe results more likely to be good than bad.
4) The hospital results were way better than expected and older trial data showed positives ........ COPD result has only to be good enough to progress to ph3 trial as a minimum?
Me also been in since 23p days - and absolutely not 'wavering'!
Reason being that MHRA emergency use approval is sure to be granted any day now? The trials were designed and executed with their full co-operation and approval. Better than expected results were delivered - and it has been said (by suitably qualified persons on ADVFN) that, given these results, it would be 'unethical' for MHRA to NOT give approval.
Surely this alone would be the catalyst for orders to start rolling in and to spark other countries around the world into similar action.
A more tenuous assumption - was Trump alluding to SYN when he was talking last night of therapeutics coming in 'days' that were not necessarily American?
I am hoping that MHRA approval is a given and will kick off a sequence of events (approvals, orders, takeover) that will be completed in the next few weeks, though I have no previous experience in such matters to support such a timescale.
COPD readout in "summer" was deliberately vague, I presume to enable RM to use it to his best advantage. The consensus here is that he must have it by now, or know what it is at the very least?
Seems most (me included) were hoping to have had them by now (especially if they are good), however, with the selling we have experienced the SP would most likely still have ended up where it is now if released too early?
I have no experience to speak of but I presume RM would prefer a strong SP when the hospital results event is held? Therefore he could use COPD data to spark real interest just a few days before hospital so that the inertia creates a snowball rather than a spike?
Nobby on ADVFN did say that there are a lot of end points in the COPD trial and could take longer than expected to complete the analysis. He also said that in his opinion they would not be able to retain the data for more than a couple days before release.
I want to believe however that RM has already had some sort of 'top level' readout - hence the interview last week and his apparent new found excitement for the hospital trial result.
I can guarantee you won't see a dip tomorrow - the MMs will be in church repenting for last weeks sins!! ;)
A long shot(?) - but I am still hoping for COPD results RNS before AGM to light the blue touch paper on this, however I also have no investing track record to be proud of so your dip is far more likely to materialise than my prediction!