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Re: flipper44 post# 433804

Monday, 01/10/2022 5:01:21 PM

Monday, January 10, 2022 5:01:21 PM

Post# of 820745
While their intentionally limited capacity at this time could be exceeded by demand if they released TLD, I do not think that would be the reason to withhold TLD since they could expand given their square foot usage and also because they have Flaskworks being currently validated. I do not think any regulator would hold the specials program and their use of 5% of their plant only initially to conserve resources for approval against them. Nor that they were in the process of validation machinery already validated for exactly this kind of production. They clearly have a practical plan in operation and they are not yet in that application process anyway.

They have a legacy plan that would likely be adequate for regulatory approval, I believe, which would include Cognate, but they probably would have to burn a lot of capital to ultimately put an agreement in place with cognate, and that would not be useful if they have a deal in the wings anyway. But I do not think it would be the reason that they have not yet published their journal article.
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