Replies to post #115556 on Biotech Values

[genisi]

PLX delay

gives Genzyme time to get their Manufacturing in order and get their oral product that much closer to the market

Plus it gives Shire time to scale-up with a new manufacturing facility.

[ghmm]

that should be 120 day not 180 day questions.

[jq1234]

Also I thought I heard PLX say they needed to meet with the FDA to get clarification on question regarding Manufacturing I took this as a potentially more serious concern maybe an innocent remark but one can never be sure.

They said the questions about CMC - testing specifications and assay validation - is very technical. That wasn't the requested meeting's main purpose. The key reason for meeting is clarification on switchover and long term extension study. Full switchover study is still on going, long term extension study lasts forever. You need clarification on what cutoff date for data submission is. Those requests usually aren't specific enough in CRL.

I actually took the delay (I figure it'll be close to a year and could even be much worse) as a bigger setback then the market did.

If PLX has this one drug without a strong technology platform, or the questions raised by FDA are questioning the technology platform, I'd agree it would have dropped much more sharply. Now it is more about timing of approval issue, so the degree of drop is logical to me.