Cell Therapy News/Articles, page-16817

First that line of credit is only needed to exstend our runway through too July - August 24. So a lot can hapen in the mean time. He may let that line of credit go or come to some new terms. Who knows.

MSB has ways to continue as a going concern regardless of the FDA. We are not in battle with the FDA, So we can conclude that MSB think the request for more proof is not unreasonable. N values of the data that validates the potancy assay are not large. What N value do they need?

The data that we have put together is remarkable, it has put to bed any effecacy issues of 001. FDA have seen 100% survival in the most at risk group. Not bad, well in some ways its a problem. It would be a very hard to reapeat the same result over many diffrent batches to raise the N value.

I would say that the data that MSB has provided has had two profound findings that the FDA have taken on board. The first is that if they are going to be tottaly reliant on a potancy assay for establishing efficacy they are going to need a high N . And they are going to need a very reliable test. The differents between a good batch and one not so good is very modest yet the results are significant.

The second is that those significant results gives them the confidence needed to grant approval for that batch regardless of the weakness of the potancy assay.

So what result would we need as a OK batch.
Good potancy assay and 100% survival at 18 months in about 4 patients. Can not be done, 18 months to long, need a short end point. Make it 6 and use change in MAP. What change? Well its not clear that we have this data however we could, perhaps more data could be found in the sub par group of 001. Lift the value a little and check in 18 months from real whorld data.

I dont think approval is coming in days, by years end, yes.