Replies to post #11380 on Pluristem Therapeutics Inc (PSTI)

[Spideyboy]

Hi Scott, I don't know, why not ask PSTI?

If they are in the presentation, then it would make sense that they are part of the trial. Why they are not there on the clinicaltrials.gov site, again I don't know, I don't have all the answers.

I will get back to you on your points but, I need to head out now. Will pick this up again tomorrow.

[Spideyboy]

Hi Scott,

Following-up here.

First of all I'm not very clear on a couple of your sentences:

When you say, "in regards to all the changes that have and are taking place in the approval process", could you clarify what changes in the approval process you are relating to?

When you say, "Through all the proper channels, they have a chance to make it through much easier with some good results in the CLI based measures." I'm not clear on who you mean by they, PSTI or Celularity, or another they?

Assuming you mean Celularity. If they get good results on measures that overlap with CLI, they will still need to start new studies with the CLI patient populations as at the moment they are only looking at DFU and the dosing related to that indication. They may perhaps be able to skip Phase I, but I would still think given this is a very new and pioneering category of medical treatment, that the FDA will be very cautious on MSC treatments and will need them to go through all the proper steps starting with Phase I. Again this therefore taking them a lot of time. It would still take them a lot of time if they were to start with Phase II.

As based on the above, Celularity would have to go through the proper process too if they change indication and patient type and dosing for the new indication, which they will need to, as you can't just make assumptions that what you did for DFU will automatically translate over to another indication and patient type.

No I don't think the Ex-FDA commissioner will be able to swing things specially for their case. Again especially not on such a pioneering new treatment method as Placental MSCs, which are injecting live cells into the body.

Going it alone does use up more capital from PSTI yes, however, imagine if/when these products prove their worth. It will quite sincerely be considered as medical breakthroughs. PSTI will not need to convince anyone to use their product, as the breakthrough with the data will create the demand. Thus while it does take hits in the development process, they can on their own easily distribute the product to hospitals with the guideline on how to thaw and inject. Saves lots of money with very few sales reps and they keep everything in house, all costs yes, but all profit too.

Personally, I believe CLI will provide 'better' data than IC, given that the severity of CLI (rutherford category 5) will create an environment which will very clearly send the messengers to recruit the effects of PLX-PAD. IC being less severe, may mean the body may send out less messengers and thus the impact of PLX-PAD may not be as good due to lower signalling to recruit their action.

But PSTI has said they have the money to take all 3 of their products to approval (CLI, ARS, Hip-Fracture), so even if IC isn't great, I think CLI will be good.

That said I have not been privy to any of the IC data and quite possibly the signalling for help is sufficient and we see great IC data. That we need to wait one more quarter to see. As you say, time will tell.