My read @ashic1 was that while the CR is on the table, it would...

My read @ashic1 was that while the CR is on the table, it would not happen at least until phase 2 has commenced. I could be wrong, but that was my understanding, and then again, companies have discretion in how and when they choose.

If I am right, and I am hoping I am, then it was made clear that efficacy data on progression of phase 2 patients would be released on a regular basis to keep market informed. The regular updates also meet the FDA protocol amendment which is allowed. I think we are allowed to 'tweak' the protocols to some extent providing efficacy is maintained and FDA are in agreement. Phase 2 is targeting up to 40 trial patients, but I noted also FDA allow that to be considerably lower.

For all intensive purposes, I came away thinking that FDA is coaching the PTX team through the process. Apologies if I am reading too much into it however.