Ann: Alterity Presents Encouraging New Phase 2 Data in MSA, page-21

Again, I am throwing this post together between meetings so I will need to be brief.

Pierre,

You would be referring to the EOP2 meeting which in my opinion is critical.

Stamler will have to give the FDA 70 days notice. This is standard.

I originally thought this meeting would follow fairly swiftly after the release of the 201 results but we haven’t heard a word so in my view there could be several reasons ...

1. ATH is not ready. You must be totally ready for this meeting, all data analysed, planned ongoing study design sorted, dosing sorted, good safety, etc, etc you should NEVER jump too early. You only get one shot.

2. Stamler is waiting for the complete 202 data set to see if it informs some of the outstanding questions.

3. A combination of both above.

4. Something left field that we have not considered (buyer negotiations, money issues, etc, etc).

Itagas,

Sorry, I’m not sure I fully understand your question. If it’s what I think it is, then the answer is very, very complex and would be better put to Stamler.

PS – I suggest you don’t dismiss Shlok’s concerns too lightly. This project is so complex, with so many moving parts, think ... ‘cutting edge of science’, that there are more questions here at the moment, than answers.

Shlok, GazBusey and amb005,

You are all raising good points in my view, I just don’t have time at the moment to get back.

KItjes3,

Yes, this is very interesting and I agree, the therapeutic range may be VERY narrow. Consider ... the 75mg dose is a 50% higher ‘hit’ than the 50mg dose. This is actually significant. Also, I not totally sure the team were super, super select during recruitment. I could expand but I don’t have time.

Dear pivalde, our super researcher,

I mentioned I was working through a theory around the ‘unexplained’ differences in the group results and then you post, as if you are in my mind ... “I would think that the biggest effect on the cellular level happens when there is a lot of labile iron during the first 13 weeks. This is the period when the UMRS score improves most with 75mg. But when there is less labile iron after these 13 weeks (we have 6-month MRIs), it may be that even 434 at high dosage starts to cause more side-effects on the cell level”.

This is very close to my thinking, for what it’s worth. This could be the issue that Stamler and the team are wrestling with and they may not actually have the ‘right’ data to clarify what is happening, when and why. Perhaps there will be a ‘cross-over’ clue in the final 202 data!! I don’t know.

My thinking at the moment is to definitely go forward with the 50mg dose, but just my opinion.

Hope I haven’t left anyone out.

As I stated, I have questions for Stamler and I hope I can get some ‘straight’ answers, even it means that they ‘don’t know yet’.

I’m out of time.

As always, only the views of one poster.