I really think that if they had disclosed the letter, this would not have been that big of a deal, and could have been partially fixed with an ASCO announcment of the parameters of a new bridging study and the good clinical data in the ASCO presentations. I could believe Wachter on not receiving the email just because it was so crazy not to disclose it, and it is not as if they waited to disclose it until they had some kind of plan or path forward, because they gave us no path forward or details of the trial today. But why not disclose it when they got the paper letter on May 21?
There are some positives, mainly the cash in the bank, ASCO is coming, and the fact that they now say they are committed to giving the FDA what it wants: correlation of OR with pain, bleeding, and infection. On the negative side, Wachter said many melanoma patients do not experience pain until very late stages, plus that pain is hard to measure. I do not know about infection and bleeding, but I wonder how common they are. Adam Feuerstein is out there and will be relentless. The stock should get crushed on Monday, as many have predicted.
What they did right was to publish the FDA letter and to hold the conference call. Wachter says they have good guidance from the FDA on endpoints and the types of patients they should enroll. Culpepper seemed confident--but who knows-- on their connections with oncologists being sufficient to recruit patients. Next week will not be fun. Diodia
dio- pvct did not give the fda the data asked for as per their letter and as I understand it, as per protocol. why not? seems either arrogant, dumb or underhanded that they submitted stats not in accordance with fda requirements. trading was halted friday for a reason. again, posit that arrogance, stupidity or underhandedness on part of pvct may be the reason. $19mm may cover their legal fees. now why do you believe this company still has a shot?
Any hope resides in the bridging study, and the fact that they have the cash to do it.
What Wachter says are the positives from the denial letter:
FDA said that they saw indication of drug activity--the drug is doing something to the tumors
They said recurrent melanoma is life-threatening, and is an appropriate disease for BTD
PVCT may submit a new request
Wachter says the agency has helped PVCT define endpoints vastly different from PFS.
Also has given good guidance on endpoints and types of patients to enroll
Negatives (which I find somewhat scary):
pain turns out to be really difficult to measure
most melanoma patients in earlier stages of disease do not have significant pain
He does not have a good way to assess pain & does not want to rely on patient self-report
I thought that correlating pain, infection, bleeding with tumor shrinkage in melanoma patients would be easy. Now it looks harder than I thought.
I am also worried about Culpepper's optimism. I believe he bought stock and exuded good cheer and confidence because he really thought they would get BTD. But they did not have the data, and I think Wachter was worried all along, but no one listened to him.
The biggest negative is Adam Feuerstein who is not going to let up. Diodia
I agree that conference call was right move. A lot of unasked questions. I would like to see them hold these quarterly. It definitely showed support from the current shareholders even if a step backwards has occurred.
My other concern was that while Wachter gave the impression they could design and SPA for phase iii now (it was a moving target previously), he didn't exactly say
how. Even if we get BTD, a phase iii will be necessary (unless AA). There is a chance results on bridging study will be strong enough to apply for AA (no one has given me a satisfactory answer on this process). Nor did they discuss what kind of funding will be needed for phase iii.
What has always appealed to me is that they have other irons in the fire. The study in combination with sorafenib could really hit the big time, but that could take quite awhile. PH-10 could get make progress and generate cash, just not in the near future.
Any way you look at it, this is a good drug that will require patience and face risks: regulatory, competition, etc ... .Those who expected to see $10 in June will have to wait atleast a year. And if it happens by then, we should all be thrilled.
I do think big pharma could navigate this faster and more surely than 4 very smart guys in Tennessee, the difference is experience and funding.If big pharma were to buy now, we would get a lot less then the numbers people have been throwing around, but a lot more than it was trading for when it went NASDAQ.
I think Wachter was confident when he exercised 650,000 shares the same day he filed the BTD application. Something happened after they sent in the application. Also Scott was confident when he exercised 25,000 shares on May 19th along with 300,000 shares in Feb.
Wachter exercised 600,000 options 6 years early on March 20th.... I think they were broadsided. Especially since the last options exercise was completed on May 19th and these options could have waited till May 27th to be exercised. I guess you would say I'm shocked....