Good afternoon all. A few thoughts on recent events.
I've deliberately not posted since the data release, because to be honest, I've been trying to grasp the true significance of the interim numbers.
While I have a scientific background, analysis of clinical trial data is definitely not part of my skill set. So although I have formed an opinion, I would ultimately defer to the interpretations of those more adept in statistical analysis.
1.Anyway with the benefit of time to reflect, I am impressed by the initial ICS data. In the 3 candidates tested, it's very positive to see results indicating an active Tc cell response to the target mucin-1 antigen. I understand that additional ICS data is imminent but I wonder why only three of the initial seven candidates have been assessed and published, given that this subgroup apparently started treatment about 2 years ago.
2.The PFS data has me in two minds. On the face of it, as of August 17th, an interim median PFS on Cvac of 365 days against 321 days on standard of care is for me encouraging but not convincing. But I can’t see it in any way justifying the falling SP since Monday.
I've taken on board a range of supporting arguments, including that the data is preliminary, can be expected to improve as the trial proceeds, is from a small sample, would be better if the initial 7 Cvac candidates were included, is comparable to or better than other approved treatments at the same stage, and so on. It was encouraging to read responses by PRR execs to questions posed by HC members. I thank those posters for their efforts.
Considered separately, I do have suspicions that the 2nd remission group data at this point appears more promising. (But discussion of whether the Canvas protocol should have included 2nd remission candidates is probably only academic at this stage.)
So for me the data trend is positive but not "exciting" at this stage.
3.Recent statements from the company suggest that they hope to use the progressive rollout of 2b data as a springboard to expand Cvac's target range. But even preliminary trials are expensive. If the SP is maintained at or around the current deflated levels, (in the absence of a partnering agreement, which imo seems unlikely at this stage), financing additional trials will almost inevitably be dilutive to existing shareholders.
4.Given the difficulty I've had in understanding the detail of the interim data announcement, and similar sentiments expressed by quite a few others, I agree that in future releases, the company could assist shareholders by providing a more 'nuts and bolts' explanation of the data and its implications.
Today’s presentation was a good step in the right direction. The webcast of the Hong Kong conference may offer another opportunity. The companies presenting at that conference are mainly ASX miners, so the audience is unlikely to be the biotech savvy mix that would attend most other PRR presentations. Dr Gargosky's explanation of Cvac function at the June shareholder briefing impressed me, and imo suggests that she could do the job admirably.
..........................................................
So for me it's all about additional data. We should be seeing plenty of that from now on.
Good luck all. Herro
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