Thinking they should agree to a clear pathway to approval in...

Thinking they should agree to a clear pathway to approval in writing for GVHD at type A meeting. May be an option for accelerating the approval in children (maybe including a small number of children in the larger trial with an earlier readout may warrant AA for children while the rest of the trial completes).

My thoughts at this stage would be open this opportunity up for big pharma to licence worldwide. Big pharma will be able to help with approvals in US and other jurisdictions worldwide. Need to give them the incentive of worldwide licencing rights (including US). Also extra incentive by giving the potential pharma partner the first right of refusal for future indications such as gastro intestinal, ARDS etc - in other words out licence Remestemcel to a big pharma worldwide for all indications. Of course for the rights hopefully we can secure an upfront payment if we make favourable terms (only mid single digit royalties). Reasoning: Big Pharma will roll out quicker and expand the pie (yes we will get a smaller slice but in total that is not all bad).

If this is favourable we can progress Rexlemestrocel for Heart and Back. I want action on these blockbusters. Vaguely recall SI indicated he had a partnership awaiting Heart with two deals depending if we got Accelerated Approval for LVAD or a cohort of patients (e.g. diabetics)? We have a real chance with LVAD in my opinion. There is no better time than now to progress this opportunity re securing funding and restoring integrity to share price. Bring on the meeting with FDA for CHF.

Likewise we have a clear pathway to approval for Back Pain. May be time to partner up in this space also and get that pivotal trial underway finally.

If we need to raise further capital I would assume it would be at much higher prices (favourable terms) if we have a big pharma partner onboard, and progressing Heart and Back trials (and potentially AA for LVAD).

Lets get moving by partnering away and taking a smaller slice of a bigger pie. These are huge worldwide markets and the sooner we progress the better IMO. Cash will follow major partnerships and we can also raise more at a better price if investors can see progress on trial results in blockbuster markets - worldwide.

To be honest I just think Big Pharma have a better skill set in bringing our technology to market, and FASTER. They have sales and marketing in place, health outcomes and economists, regulatory specialists globally, and vast experience getting regulatory approvals worldwide. We need to make the most of our potential first mover advantage. Going it alone and putting major trials on 'ice' is a false economy IMO.

In short USE PHARMA EXPERTISE. Do not fight it. Time is not on our side.

Also time to get a new CEO or Senior Executive that has experience with big pharma partnerships.