ILAP timeline

[biopearl123]

150 days from completed application. I submit that virtually everything could have been submitted on day one (ok day 2), all the application papers (team in place for months before filing), RWD (Kuykendall study (12 months MOS), Janssen insurance data (7 mo MOS), PII study with comparator arm for MF and PII TI data from MDS study and new molecular end point data not available at the time of FDA submission (or if it was the FDA dissed it). This may be what the ILAP pathway requires. If so 150 days from submission (late Feb) but if they require PIII data then we are on a similar timeline as the FDA/EMA.

[cheng_ho]

All of which would have been VERY appropriate for Scarlett to bring up at the Investor Conference.

Instead, he evaded mentioning ILAP even in passing. Why?

[biopearl123]

Correction, late March.

[biopearl123]

Bill, you know very well why. Dr. Scarlett has made it very clear that he will not discuss regulatory issues. As we all have seen, it opens the door to lawsuits and potential disappointment. By not discussing it, it could lead to a different door when the time comes, pleasant surprises, income and stock appreciation. Nothing to be gained now by mentioning ILAP. bp