Hi Scott,
Thanks for the questions and apologies the delay. It was a busy weekend.
1. I feel that it would make sense that having a management team with more direct experience in the pharma biotech world would be ideal. Generally I do feel that such veterans are better able to secure good for promising technology prior to approvals.
That said I would like to look at the management team from 2 standpoints to note that while not ideal I think what we have is 'ok'.
a) While Zami was not previously of the biotech space, he does have a lot of experience as president or similar in multiple companies, therefore while he does not have the, prior to PSTI, pharma biotech experience, all of those past experiences combined should mean that he has an idea of how to run a company. Companies aren't wildly different when talking about top level management so top level industry experience is most important. Though again if he has the prior pharma biotech experience, he would likely be more connected in our field which would aid in faster progression.
b) the other key element in this kind of company is of course the science and smart R&D efforts. This lies under Dr. Lukasiewicz-Hagai. From her bio on the company web-page, she seems to have the capabiities at hand, from Director of Global R&D at Teva in Biosimilar spaces, Clinical Trial experience, to PhD in Biostatistics. She also appears to have Haematological and Orthopedic experience, which are our key areas. So it would seem she is well placed vis-a-vis scientific development.
So with these 2 key things, I feel we are ok.
With regards Yaky, I can't say I'm as impressed. His potential in the contacts area doesn't seem to have done much. It would seem Zami and Yaky know and trust each other, whether for good or bad, can't say. I would like to see more value from him.
2. As far as I can see, no it does not appear that their bonuses were justified as yet. I hope we will soon be able to see something that would indicate otherwise. I hope that the Co-CEO structure is for a separation of responsibilities on Commercial vs Government focus, as mentioned a long time ago by someone on this board. I feel that would make the most sense.
3. Not specifically, while we might not like the method in which they go about getting more funds, 6-10 months prior to lights out to secure more funding is easy enough.
4. No I do not see any special benefit of these shows so far. If the products are confirmed to do what we hope they can, then they will essentially sell themselves. Doing shows and getting your work out there is important, but they could perhaps be more focused and cut down on those. Though also I feel the costs saved from going to less shows wouldn't be something significant. So in the grand scheme, spending money on the shows for me is a moot point.
5. I get your point here and I'd say it's a bit of both. But overall, yes I would be happy to say we are a phase III, regards the need for one more trial is enough to get us marketing approval.
On your point with the low sample size to date. I agree with you that traditionally speaking the sample numbers are low. However when looking at the sample you need and effects it is important to look at the treatment product, the MOA and the safety efficacy signals seen.
In particular with PSTI's products they are dealing with stem cells and their targets which are all grow from DNA encoded in mammalian Homeobox genes. These genes are exceptionally well conserved between a great multitude of species but even moreso when we look at the homebox's within the mammal Class. The more essential the genes the more ubiquitous they are within a class. As example of this, mice, while looking very different to humans share about 92% of human DNA. As I'm sure we can all appreciate formation of placenta, veins and arteries as well as bone and Red White Cell and platelets are among the most conserved genes. Because we are using and targeting such fundamental elements of mammalian development, I am not surprised that we have been able to see such aligned results from mouse to human data so far.
Therefore I would not think that we would need particularly large samples, especially with the low standard deviations seen in the data. This is also clearly what the regulators have taken into account so as to let PSTI progress with comparatively low numbers.
one of these larger scale studies should suffice for approval and so yes again we are at Phase III.
6. From what I understand, the key benefits of fast track are
a) more frequent comms with the FDA
b) the ability to provide your filings on a rolling basis
c) If all goes well with meeting fast track criteria, upon submission of the last data, the FDA follows with Priority Review so that you should get feedback within 6 months.
So no I do not think it would be anything like 2 weeks to 90 days. Perhaps in total the perks could get you 10 months earlier approval compared to normal, but we would definitely need quite a few months following the submission of the final piece of supportive data.
Regards R18 though, perhaps the military can usher things along faster simply based on the most basic to assess metrics. Maybe, this basic positive data could allow them to stock-pile in anticipation of upcoming approval? Pure conjecture here and with taking into account the recent bill giving the military more of a sway on this.
Definitely the science and the R&D team winning compared to overall management. The science really seems astounding. The last bit of additional data that PSTI came out with last week with additional CLI murine study was quite amazing, though it appears free access to the article has been removed and only now as paid content on Cytotherapy "The journal of cell Therapy". Fortunately I was able to read it in full and I saw no problems in study design or questionable reporting. Wish I had downloaded it though. Your call on how comfortable you are with the Mouse-Human similarities, but as I mention given the targeting of such fundamental aspects, I'm not too concerned.
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