AnalystsSome analysts are either blind or deaf to the fact that this entire fiasco is solely due to a decision of the FDA to add more quality controls to the production process. It is clear to me that regardless of the amount of quality controls PLI had in place, the FDA would have asked for more. I find interesting that Maruoka is lowering chances of success for Ryplazim, on top of increasing the discount given to to its plasma products following the FDA decision, when it is in now way less safe or successful than prior to the decision.
Ryplazim is in no way less successful than it’s ever been or ever will be, but only DELAYED for use and sales. Although quite a major setback, it’s in no way due to a company failure, but rather a request for more quality controls by the FDA. If PLI had 3 quality check, they would have asked for 5, 6 for 9, or 7 for 11. Total nonsense to me, but the FDA is boss. When all said and done, the product will be approved, end of story.
balain