The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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Motley Fool aren't much better. Damned fence sitters imop.
I’m in
So I ain’t deramping
Topped up and borrowed to do so at 101
So I’m am v v much all in
I’m just so confused about constant drop
But delay is time. Time is money. If it works on breathless COVID non COVID it has huge future
If you build it they will come
That’s how I feel
Despite your negativity we keep rolling forward toward approval.
It must really pain you that your deramping is so ineffective
Dosed 1 person a day! Country ravaged by disease and 300 million people?
Hardly inspiring
But as we all say
If it works it doesn’t matter
sorry 2->3
ACTIV2 inclusion RNS 25th Jan
ACTIV2 first patient dosed 15th Feb
Dr Castro thinks 110 dosed "in the next few weeks"
If we assume by 10th June, that would mean 4 months to get 110 done. And he says circa 1000 for P3 ACTIV, though that number will be decided later from a power calculation after the ACTIV2 readout. The rate of recruitment is not fast but would be much quicker for ACTIV3, if it happens, as sites will be fully set up and used to using it. Indeed the USGov may add lots of sites to those drugs that progress from 2 ->3 as they have cleared the first hurdle and will be seen as more worthy of focussing on? All IMHO
Thanks Alphageddon, really interesting. I was drafting an email to Synairgen to point out that there are a few of the inclusion criteria for the other ACTIV2 trial drugs that make sure the patients enrolled are higher risk. I had been hoping it might have been possible to only recruit significantly breathless patients for SNG001 in ACTIV2. I can see it is too late to change pre-P3 ACTIV. The good news is that if any signal is visible at all, and the FDA/USGov have access to our HT too, they may commit to a full P3 home ACTIV in only those that are markedly or severely breathless on the OSCI scale at presentation.
Anyway we will have 110 more patients that will add to our safety data, and may add to a meta-analysis no the subgroup that the HT science has indicated we should focus on - marked or severe breathlessness.
I am somewhat concerned that ACTIV2 seems to have disappeared from the Synairgen site apart from the news of inclusion and first dose. Hopefully that is not a bad sign. Great to hear Dr Castro thinks it will be weeks until last dosed SNG patient in ACTIV2!!
Great news and I’m sure all those people who’ve been complaining about a lack of activ2 mention from RM will be along shortly to appreciate this good news.
But I won’t hold my breath
Kansas have enrolled over 40 patients themselves on to Activ - 2. Roughly 6 of those have been enrolled into the inhaled interferon arm of the trial. Available for mild out-patient cases. "Exciting to find out the results as its an at home treatment". Completing P2 next few weeks (110 patients across US sites). Then results will be reviewed by FDA and then they will make a decision to go to P3 which will be 1000 patients.
SNG interferon question and answer is from 35 minutes in
https://www.facebook.com/watch/live/?v=1116924078826762&ref=watch_permalink
in answer to a question on Activ-2 trial for inhaled interferon they said they expect P2 trial to complete in "next few weeks"