"Good vibes Here Dudes"....., page-29

If you look at what is being said by MSB now regarding the FDA, GVHD is GVHD (kids/adults/other), which is in line with what I always thought.

At ODAC, answering a question about MAP, but not really answering it so directly in Fred's case, Fred Grossman and Silviu gave differing answers - Fred stressed that there was a signal in early data - early trials that suggested kids respond differently (which was apparently true about the early trial but wasn;t what was asked). Silviu answered what was asked (I'm speaking from memory I don't have the hard copy in front of me) which was that on the MAP score there wasn't a difference between pediatrics and adults - which I think is also true.

In my own personal opinion - I do not know if there is a difference between adults with GvHD and children but I do know there is a difference in the immune systems of adults and children and the immune system and tolerance - training of T cells etc does differ - in adults the thymus attropies - it dies off substantially - so there could be a difference as GvHD much be an immune related phenomenon. And the adult and children immune organs and cells are different.

BUT the MAP tool is a pretty blunt surrogate tool. It looks at Reg3alpha and ST2 and if I recall correctly these are to do with inflammation in the intestinal crypts of the gut producing markers detectable in the blood - and the MAP tool (above and below 0.291 from memory) doesn't distinguish between adults and kids (unless of course adults and kids happen to differ in their likelihood of being above or below that 0.291 number.

I don't think and I don't think SI thinks, I've now listened twice to his recent webinar post the CRL, that there is much practical difference between kids and adults so I do think if he gets good data on adults that that would be persuasive for both kids and adults. But SIs problem is that he talks in abstract terms so much that most of what he says isn't understood by most listeners and some of what he has said in the past - like that there is a difference between adults and kids - tends to be recalled by those that don't understand what he is saying when he speaks in general terms.

I am never to be relied upon - obviously.

I disagree.How much you are to be replied upon depends on what you include in your posts.

When you provide links - like you did showing Kilian Kelly had made a statement you are more reliable that either someone that does not (and you are much more useful that someone saying like "yeah cynutters" or something - I prefer that sort of post anyway - I find that reliable) but when you string a bunch of impressions together (which pretty much everyone does) and then present your overall impression as if it is so, then your conclusion is only as good as each of the assumptions.

Same applies for me.

I reckon give no one credit for being correct unless you can follow their chain of reasoning (you, in my opinion, do just fine on the not trusting authority front). I encourage you to keep not trusting authority.

This comment is particularly for you - I invite you to listen again or for the first time to the recent MSB webcast.

If I recall correctly you have previously posted concerns about the linkage between SI and some funders around CR times. That certain folks might be getting better briefings - sort of inside info. In the recent webinar I got a hint of something like that in the question from John Hestor of Bell Potter. Hestor seemed to me to have had information that I had not previously had - like that the FDA had told MSB certain things and MSB had passed those things on the Bell Potter - JH and someone called Mark or Mattew, and that JH as a consequence thought that the FDA were shifting the goal posts around.

I do not think the FDA have shifted the goal posts and I also think the FDA has not spoken to JH or Bell Potter about MSBs business but that rather JH and Bell Potter are getting the FDA's take entirely second hand from MSB and SI. So if SI misunderstands or incorrectly characterises the FDA position the Bell Potter then they will be surprised if they believe SI.

I interpretted that as being what happened from the exchange with JH and SI on the webinar. I also think the autotranslate that produces transcripts mistranslated "let alone" as "the lone" when there was a reference to analysts. I think JH was complaining as an analyst about how hard it is to get the calls right (him being an analyst and him advising clients), not just sympathising with SI as the lone analyst.

I have had difficulties with MSB folk for offering my interpretation on communications before -so I'll stress the above is just my opinion - I would value your opinion on that exchange if you care to listen and to offer one. You don't seem to care too much for tick counts and form independent opinions - I like that about you pledge.