Ann: Investor Presentation, page-527

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gavint66

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19/06/24

09:19

Post #: 74382257
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Originally posted by Bazsa: ↑

First I ask holders here , what is the outcome for CYP if MSB gains approval or not? My view is that CYPs future lies in some ones success of getting something across the line. CYP would then be able to work in reproducing the product at much larger scale and cheaper. When someone has a good potency assay you should be able to tweak the process , possibly from original cell source and effectively match the product.

It seems that @truss20 may have missed some of the progress MSB have made over the last 4 years.

"Essentially, MSB were unable to get approval of Rem-L in paediatric Gvhd. This was/is due to the current clinical trial data being not being adequately controlled and related potency assays were not sufficiently related to the mechanism of action."

This would be a good summary of facts recorded in CRL 1
We have moved way past those dark times, as we had the first Type A meeting, the results, we had to fix the potency assays before progressing clinical trials. It was not a clinical hold as the FDA continued to allow us to use the cells on compassionate grounds. We know just over 70 adults had been given the treatment after CRL 1

More importantly is the outcomes of the COMPLETE RESPONSE of BLA 2 . We had some good outcomes, the FDA did not question efficacy of 001. It has been deemed successful and well controlled. Matching patients and then following them is actually better than a RCT because it takes into account current standard of care. To confirm this a statement was released by a very high US expert " the outcomes in children are compelling "

As all know we still got a CRL . The reason given. We ( FDA) can not be assured that current stock would be as same that was used in 001. More confirmation that 001 has been found good. Please provide more data to show that current stock is the same as used in 001. After the 2 type A meeting the FDA concluded that they could not approve due to what they considered lack of having a adequately standardised product SI points to the regulation. This is the opinion of the FDA.

So how well was the product standardised in 001?
Out of 11 lots used in 001 just 2 had minimal impact on results on entry level data from patients in 001 but wouldn't it be likely that without treatment those results would have been negative.

Could it be considered the product was standardised appropriately for a P3 trial, FDA may have even made a similar mistake to what JB has.

Next , why would SI miss represent statements from the FDA ?
Sue is keeping a eye on things. FDA may make public comment to counter false or misleading claims.

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I can agree with all of that Bazz however research has suggested that in the reproduction process mutant replication may lead to tumours.

If this is yet to be proven or unproven, it is still a published concern in articles, as research continues and indicates a concern for mutant compromised cells during manufacturing.

With this as a major concern I can't see the FDA rushing to sign off on this novel therapy for many years to come until completely proven to be safe.

CYP Price at posting: 30.5¢ Sentiment: None Disclosure: Not Held
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Ann: Investor Presentation, page-527

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