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Post by ytseschew on Nov 24, 2015 13:00:19 GMT
It's easy to say these things in hindsight, but I've been thinking that Ocata management's biggest mistake in the past year was not moving forward with the SMD trials in Europe as soon as they were able to. I understood, at the time, that they wanted to synchronize the US and EU trials in the hopes that they would be able to use both to help power their trials, but as soon as had any hint that the US was going to take longer than expected, they should have immediately started the trials in Europe. I believe that they had the pivotal status in the EU by December of 2014 (perhaps earlier). If they had begun trials by say March of 2015 then they would have nearly 8 months worth of data on the first patients. Presumably the younger SMD patients would have been easier to find since they would have more tolerance for immunosuppression and fewer health problems. Assuming good results, this would have given them many benefits, including more data to give to the FDA to support the idea of an SPA, a stronger position of negotiation with Astellas, and potentially a higher stock price when diluting shares. All that while getting them closer to selling a treatment in Europe. While I imagine that they did not foresee the length of the delays with the FDA, their experience should have told them that it was a good possibility. It's unfortunate that they're not further along with the EU SMD trials. Even now they could get going with them without any further delays (which seem likely from the FDA). Perhaps Astellas will be smart enough to start them.
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Post by nateb on Nov 24, 2015 14:29:58 GMT
As always, the science ocata and Lanza brought to the table never failed to impress. The management and ability to execute is where it fell short. Another excellent example of that here. Management was(is) highly compensated but we certainly didn't get our money's worth in my opinion .
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Post by forthefuture on Nov 24, 2015 14:32:56 GMT
It's easy to say these things in hindsight, but I've been thinking that Ocata management's biggest mistake in the past year was not moving forward with the SMD trials in Europe as soon as they were able to. I understood, at the time, that they wanted to synchronize the US and EU trials in the hopes that they would be able to use both to help power their trials, but as soon as had any hint that the US was going to take longer than expected, they should have immediately started the trials in Europe. I believe that they had the pivotal status in the EU by December of 2014 (perhaps earlier). If they had begun trials by say March of 2015 then they would have nearly 8 months worth of data on the first patients. Presumably the younger SMD patients would have been easier to find since they would have more tolerance for immunosuppression and fewer health problems. Assuming good results, this would have given them many benefits, including more data to give to the FDA to support the idea of an SPA, a stronger position of negotiation with Astellas, and potentially a higher stock price when diluting shares. All that while getting them closer to selling a treatment in Europe. While I imagine that they did not foresee the length of the delays with the FDA, their experience should have told them that it was a good possibility. It's unfortunate that they're not further along with the EU SMD trials. Even now they could get going with them without any further delays (which seem likely from the FDA). Perhaps Astellas will be smart enough to start them. Imo, what caused the downfall was never having a plan B. |
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