Good morning from London. Stayed up and listened to the presentation and the “calls” so a little short on sleep which may explain a little.
First of all there has been some super sleuthing posted on this forum over the past few months. @dachopper, @LearningEachDay, @Wilba32, @Phaedrus, and others, have kept me informed along with the occasional “missive” from @otherperspective” “schooling” some of more erroneous posters, hell bent on avoiding any objectivity when it comes to data. Thank you all.
My whinge (back to lack of sleep?) is the presentation but even more the questions after. OK we have slipped down the table of importance and only 2 “analysts” were asking questions, but it would be great if “Mr Analyst” could avoid mumbling and sharpen up a little.
All roads lead to Rome and the approval of GVHD. Except to get on that road we need to travel in the juggernaut called “Agreed Potency Assay” (nice name for a truck). Without APA the journey doesn’t start, however once on board we start building momentum towards that approval and all the other therapies that will follow.
Now there maybe a plan B and SI will be working on it, but as the share price shows we are limited and it seems to me that we as shareholders (given our average share price purchase) need plan A to work to reduce the risk of some rather unpleasant dilution.
Plan A, manage cash burn to last until approval of REM-L for SRGvHD by the end of the year. The use of the accumulated inventory becomes our cashflow positive moment and the share price increase will see the additional funds by the way of shares issued to the Surgcenter investors and I expect the additional $40m of available borrowing. It will fund our back trial and while we are collaborating on Ards I think NIH will provide the money subject to APA.
Plan B, I do not include Heart as I expect that it will have to be as was always intended to be a joint venture. But as a share issue at these prices is a horrible thought. Plan B will mean giving up something somewhere.
So we need a little luck, the FDA need to keep to their timings and SI and his team need to keep finally to their timings that for one reason or another (and I expect it may in some cases be because of circumstances outside of their control) they have been consistently inconsistent in meeting. That slippage cannot continue and I would have liked our “analysts” to have challenged SI on that. When exactly in this quarter, what exactly is outstanding? Then all we can do is hope the FDA respond in their agreed standard timelines. Good news about the mock facilities inspection.
With APA our outstanding data becomes relevant, the Juggernaut starts rolling and provided we can avoid an opportunistic takeover while building up speed, it will be unstoppable.
My sentiment is my view of APA happening.
Regards
Yelrom
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