Lybalvi?

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The FDA rewards innovative technology and true breakthrough products. Alkermes isn’t that company. Grabbing old generic cheap stuff and and repurposing with a new spin is not innovation. WS would respect it more if pops just came out and said we aren’t innovative but by selling 50 year old products we can turn a profit .
We are all here because they pay well and the culture was good till Austin Powers arrived.
 


















anonymous said:
Obviously not a "non -issue" or the drug would have been approved on the PUDFA date
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I'm hearing some rather alarming things. Launch delayed until 3rd quarter????! Addition of tons of virtually impossible to sell baggage to our label???! I'm starting to not be real excited about this thing potentially getting approved. Could someone in the know please give us an update?

Pretty reliable sources have been spewing the negative information I'm hearing above. Is this thing actually going to get approved?? If it does get approved is the label going to be so harsh it's not worth launching???
 






Read the press release on why the delay of 3831. It was due to the coating process of the tablet that has to be resolved at the manufacturing plant. Had nothing to do with efficacy, side effects, or other issues relative to the label.
 






anonymous said:
Read the press release on why the delay of 3831. It was due to the coating process of the tablet that has to be resolved at the manufacturing plant. Had nothing to do with efficacy, side effects, or other issues relative to the label.
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So what you're telling us is that the clinical and safety review and label have been completed??? Those weren't stopped when it was found we had a problem producing our tablets??? Well then, you would be the only one who thinks that the clinical and safety and label have been completed. You seem to be quite ignorant because you are wrong. All clinical and safety review was stopped until we can show we can produce the product. After we show that the clinical, safety and label review will be taken up again. That's what I'm being told and that is why we believe launch wont be until July if approved.

Ya know, we were also told 5461 would be a slam dunk and easily approved. Did you believe that too???? Moron.
 












anonymous said:
Read the press release on why the delay of 3831. It was due to the coating process of the tablet that has to be resolved at the manufacturing plant. Had nothing to do with efficacy, side effects, or other issues relative to the label.
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Oh, I forgot take everything that Pops and team threw in a press release as gospel. Never mind.
 












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